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EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue.
Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S.
A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml).
Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate.
This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.
Injectate randomization:
Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in a 1:1 ratio. Randomization will occur at the site using envelopes provided by the Investigator. The envelope's contents will specify the treatment assignment for each patient and opened by the research team (PI will be blinded). The investigators will monitor the safety and effectiveness data. The appropriate solutions will be injected into the submucosal space beneath the lesion(s) to be excised before the lesion(s) is/are removed. Subjects in both groups will receive the appropriate volume of injectate deemed necessary by the PI for the individual patient.
Sample size and Statistical Analysis At least 200 patients will be enrolled. 100 of these patients will be randomized to Eleview injectate and 100 will be given the standard of care, Hetastarch injectate only. Efficacy and safety of Eleview injectate has only been reviewed in one previous study. Therefore, the planned sample size was not calculated using a statistical power analysis, but was regarded as sufficient to repeat the objectives of the COSMO study (2017) and satisfy the exploratory purposes of the present study.
Study personnel will carry out a simple randomization using a commonly used online generator. Randomization assignments will then be sealed until day of procedure until patient eligibility has been confirmed. The Principal Investigator will remain blinded and will perform all data analysis after completion of the study.
Data will be summarized and compared using classic descriptive statistics, i.e. mean, standard deviation, coefficient of variation (%), minimum, median and maximum values for quantitative variables, and frequencies for qualitative variables.
The Sydney Resection Quotient will be compared between treatment groups using a Wilcoxon Rank-Sum test. The proportion of subjects with en bloc resection of all endoscopically visible lesions will also be compared between treatment groups using a Fisher's exact test. A nominal alpha level of 0.05 will be used for both the comparisons.
No formal comparison will be performed for the secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eleview | Active Comparator | This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. |
|
| Hetastarch | Active Comparator | This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleview | Drug | If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| Sydney Resection Quotient (SRQ) | Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ. | During the large polyp removal |
| Measure | Description | Time Frame |
|---|---|---|
| Injected Volume Needed for Initial Lesion Lift | Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch. | During initial injection portion of large polyp removal |
| Injected Volume Needed for Complete Removal of Lesion |
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Inclusion Criteria:
Exclusion Criteria:
Age: Subjects is under 18 years old
Consent: Vulnerable subjects including those who are unable to consent
Pregnancy: Pregnant or breastfeeding women
ASA score <3
Physical findings: Abnormal physical findings that may interfere with the study objectives
Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days
Excluded lesions:
Previous partial resection or attempted resection of the lesion
Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs
Severe liver disease.
Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon,
Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease
Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR>1.5).
Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study.
Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Rex | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22678327 | Background | Fasoulas K, Lazaraki G, Chatzimavroudis G, Paroutoglou G, Katsinelos T, Dimou E, Geros C, Zavos C, Kountouras J, Katsinelos P. Endoscopic mucosal resection of giant laterally spreading tumors with submucosal injection of hydroxyethyl starch: comparative study with normal saline solution. Surg Laparosc Endosc Percutan Tech. 2012 Jun;22(3):272-8. doi: 10.1097/SLE.0b013e318251553c. | |
| 18656592 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eleview | This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
| FG001 | Hetastarch | This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eleview | This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sydney Resection Quotient (SRQ) | Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ. | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | Ratio | During the large polyp removal | Large polyps | Large polyps |
|
1 month
Patients were called approximately 30 days after their colonoscopy procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eleview | This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural Bleeding | Injury, poisoning and procedural complications | Systematic Assessment | Bleeding that occurred during the colonoscopy |
limitations include single-center, single-endoscopist design which could limit the generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | Indiana University | 317-948-0724 | rlahr@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2018 | Oct 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000706807 | SIC-8000 |
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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The Investigator is blinded to the randomization process but can be unblinded after the product has been dispensed if the patient has a medical issue that requires it.
|
| Hetastarch | Drug | If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
|
|
Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch |
| During the large polyp removal |
| Number of Re-injections Needed During Resection | Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection. | During the large polyp removal |
| Number of En Bloc Resections | Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch | During the large polyp removal |
| Number of Pieces Resected Using Snares | Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch. | During the large polyp removal |
| Mound Concentration Diameter | Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be. | During the large polyp removal |
| Mound Concentration Height | Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be. | During the large polyp removal |
| Mound Duration | Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating. | During the large polyp removal |
| Ease of Injection | Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult. | During the large polyp removal |
| Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect. | During the large polyp removal |
| Time Required to Remove the Lesion | Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion) | During the large polyp removal |
| Safety Outcomes as Assessed by Complications During or After the Procedure | To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate. | during large polyp removal through 30 days post procedure |
| Background |
| ASGE Technology Committee; Liu J, Petersen BT, Tierney WM, Chuttani R, Disario JA, Coffie JM, Mishkin DS, Shah RJ, Somogyi L, Song LM. Endoscopic banding devices. Gastrointest Endosc. 2008 Aug;68(2):217-21. doi: 10.1016/j.gie.2008.03.1121. No abstract available. |
| 26077453 | Background | ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12. |
| 31288028 | Derived | Rex DK, Broadley HM, Garcia JR, Lahr RE, MacPhail ME, McWhinney CD, Searight MP, Sullivan AW, Mahajan N, Eckert GJ, Vemulapalli KC. SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. Gastrointest Endosc. 2019 Nov;90(5):807-812. doi: 10.1016/j.gie.2019.06.040. Epub 2019 Jul 6. |
| BG001 | Hetastarch | This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of lesions randomized in the study | Number | Lesions |
|
| OG001 | Hetastarch | This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. |
|
|
| Secondary | Injected Volume Needed for Initial Lesion Lift | Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch. | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | milliliters | During initial injection portion of large polyp removal | Large polyps | Large polyps |
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| Secondary | Injected Volume Needed for Complete Removal of Lesion | Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | milliliters | During the large polyp removal | Large polyps | Large polyps |
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| Secondary | Number of Re-injections Needed During Resection | Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection. | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | reinjections | During the large polyp removal | Large polyps | Large polyps |
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| Secondary | Number of En Bloc Resections | Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch | There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 84 adenomas and 30 serrated lesions included in the Eleview arm. For the same reason, there are 81 patients but 75 adenomas and 27 serrated lesions in the Hetastarch group. | Posted | Number | Polyps | During the large polyp removal | Large Polyps | Large Polyps |
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| Secondary | Number of Pieces Resected Using Snares | Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch. | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | polyp pieces resected | During the large polyp removal | Large polyps | Large polyps |
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| Secondary | Mound Concentration Diameter | Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be. | There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group. | Posted | Number | Polyps | During the large polyp removal | Large Polyps | Large Polyps |
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| Secondary | Mound Concentration Height | Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be. | There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group. | Posted | Number | Polyps | During the large polyp removal | Large Polyps | Large Polyps |
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| Secondary | Mound Duration | Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating. | Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm. | Posted | Number | Polyps | During the large polyp removal | Large Polyps | Large Polyps |
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| Secondary | Ease of Injection | Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult. | Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm. | Posted | Number | Polyps | During the large polyp removal | Large Polyps | Large Polyps |
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| Secondary | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect. | There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group. | Posted | Number | Polyps requiring additional treatments | During the large polyp removal | Large polyps | Large polyps |
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| Secondary | Time Required to Remove the Lesion | Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion) | Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps. | Posted | Mean | Standard Deviation | minutes | During the large polyp removal | Large polyps | Large polyps |
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| Secondary | Safety Outcomes as Assessed by Complications During or After the Procedure | To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate. | There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group. | Posted | Number | Polyps | during large polyp removal through 30 days post procedure | Large polyps | Large polyps |
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|
| 0 |
| 77 |
| 0 |
| 77 |
| 16 |
| 77 |
| EG001 | Hetastarch | This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. | 0 | 81 | 0 | 81 | 15 | 81 |
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| Delayed Bleed | Injury, poisoning and procedural complications | Systematic Assessment | Bleeding that occurred after the colonoscopy procedure |
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| Abdominal Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Type 3 Deep Mural Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| D011134 |
| Polysaccharides |
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| Serrated |
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| Serrated Lesions |
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| Serrated Lesions |
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| Serrated Lesions |
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| Serrated Lesions |
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| Inadequate |
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| Inadequate |
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| Inadequate |
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| Unknown |
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| Difficult |
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| Very difficult |
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| Unknown |
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| ablation |
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| Serrated Lesions |
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| Post procedure abdonimal pain |
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| Perforation |
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