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| Name | Class |
|---|---|
| US Endoscopy | INDUSTRY |
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The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (Standard Colonoscopy) | No Intervention | Standard colonoscopy with no device attachment. | |
| EndoRings Colonoscopy | Experimental | Colonoscopy with EndoRings device attached to the distal end of the scope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoRings device | Device | Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rates | Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings. | During colonoscopy procedure |
| Number of Adenomas Per Colonoscopy | Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy. | During colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection Rate | Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings. | During colonoscopy procedure |
| Number of Detections Per Colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31299257 | Derived | Rex DK, Kessler WR, Sagi SV, Rogers NA, Fischer M, Bohm ME, Wo JM, Dewitt JM, McHenry L, Lahr RE, Searight MP, MacPhail M, Sullivan AW, McWhinney CD, Vemulapalli KC. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial. Gastrointest Endosc. 2020 Jan;91(1):115-120. doi: 10.1016/j.gie.2019.06.042. Epub 2019 Jul 9. |
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De-identified data may be shared upon the discretion of the principal investigator.
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592 patients were enrolled in the study, but 17 were excluded before randomization for not meeting inclusion criteria. 569 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | EndoRings Colonoscopy | Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure. |
| FG001 | Control Arm (Standard Colonoscopy) | Standard colonoscopy with no device attachment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EndoRings Colonoscopy | Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure. |
| BG001 |
| 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 | Adenoma Detection Rates | Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings. | Posted | Count of Participants | Participants | During colonoscopy procedure |
|
During the colonoscopy procedure and while the patient was in the recovery section of the endoscopy suite immediately after the 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 | EndoRings Colonoscopy | Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure. |
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Single center design; Inability to blind endoscopists to device randomization; Most patients were sedated with propofol so it would not reasonably be expected to have a difference in patient comfort score
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lahr | 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 | Jan 22, 2018 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
| During colonoscopy procedure |
| Total Number of Detections | Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy. | During colonoscopy procedure |
| Cecal Intubation Rate | Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy. | During colonoscopy procedure |
| Time Comparison for Each Method | Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal). | During colonoscopy procedure |
| Patient Comfort Score | Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome). | After colonoscopy was completed while patient was in recovery area of endoscopy unit |
| Problems Encountered With Equipment | Occurrences of slippage of EndoRings or of device being removed on insertion. | During colonoscopy procedure |
| Control Arm (Standard Colonoscopy) |
Standard colonoscopy with no device attachment. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Indication for Colonoscopy | Colonoscopy in patients without previously discovered polyps and for no other reason than screening for colorectal cancer is termed Screening colonoscopy. If the patient had polyps in a prior colonoscopy, then the indication would be Surveillance colonoscopy. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Adenomas Per Colonoscopy | Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy. | Posted | Mean | Standard Deviation | adenomas per colonoscopy | During colonoscopy procedure |
|
|
|
| Secondary | Polyp Detection Rate | Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings. | Posted | Count of Participants | Participants | During colonoscopy procedure |
|
|
|
| Secondary | Number of Detections Per Colonoscopy | Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy. | Posted | Mean | Standard Deviation | polyps per colonoscopy | During colonoscopy procedure |
|
|
|
| Secondary | Total Number of Detections | Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy. | Posted | Number | Detections | During colonoscopy procedure |
|
|
|
| Secondary | Cecal Intubation Rate | Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy. | Posted | Count of Participants | Participants | During colonoscopy procedure |
|
|
|
| Secondary | Time Comparison for Each Method | Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal). | Posted | Mean | Standard Deviation | Minutes | During colonoscopy procedure |
|
|
|
| Secondary | Patient Comfort Score | Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome). | Posted | Mean | Standard Deviation | units on a scale | After colonoscopy was completed while patient was in recovery area of endoscopy unit |
|
|
|
| Secondary | Problems Encountered With Equipment | Occurrences of slippage of EndoRings or of device being removed on insertion. | This outcome measure is not applicable for patients randomized to the standard arm because there is no device attached in the standard arm of the study. For this reason, 0 patients are reported for the standard arm for this specific outcome measure. | Posted | Count of Participants | Participants | During colonoscopy procedure |
|
|
|
| 0 |
| 284 |
| 0 |
| 284 |
| 0 |
| 284 |
| EG001 | Control Arm (Standard Colonoscopy) | Standard colonoscopy with no device attachment. | 0 | 278 | 0 | 278 | 0 | 278 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Total Procedure Time |
|