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The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoRotor Resection Arm | Other | All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoRotor Resection | Device | The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. | Index Procedure through 90 Day Post Procedure Follow-up Visit | |
| Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Index Procedure through 90 Day Post Procedure Follow-up Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. | Index Procedure | |
| Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. | 90-day follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Costamagna, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States | ||
| Centre Hospitalier Universitaire (CHU) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38042207 | Derived | Knabe M, Maselli R, Cesbron-Metivier E, Hollerbach S, Petruzziello L, Prat F, Khara HS, Pioche M, Hartmann D, Cesaro P, Barbaro F, Berger A, Spada C, Diehl DL, May A, Ponchon T, Repici A, Costamagna G. Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study. Gastrointest Endosc. 2024 May;99(5):778-786. doi: 10.1016/j.gie.2023.11.050. Epub 2023 Dec 1. |
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The study was over-enrolled. The protocol required 60 subjects; however, 66 subjects were enrolled and treated of which 62 completed the study.
Participants were recruited at 12 centers in the US and Europe. First participant was enrolled in the study on January 25, 2018 and the last participant was enrolled in the study on June 24, 2020.
Of the 80 patients screened for this study, 66 were enrolled and treated with EndoRotor.
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| ID | Title | Description |
|---|---|---|
| FG000 | EndoRotor Resection Arm | All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | EndoRotor Resection Arm | All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection. |
| 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 | Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. | Primary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit. | Posted | Count of Participants | Participants | Index Procedure through 90 Day Post Procedure Follow-up Visit |
|
Index procedure through the 90 day post procedure follow-up visit.
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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 | EndoRotor Resection Arm | All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucosal Laceration | Injury, poisoning and procedural complications | Systematic Assessment | Onset time: Procedure Severity: Severe Relationship to EndoRotor: Unlikely Relationship to Procedure: Possible Action Taken: Clipping and Hospitalization Outcome: Recovered |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Polypectomy Syndrome | Gastrointestinal disorders | Systematic Assessment | Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: not related Relationship to procedure: related Action taken: medication Recovered |
COVID pandemic made follow-up at each center difficult or impossible for patients who had a 90 day follow-up from March 2020 and beyond. Most of Europe was on lockdown from this point through June 2021.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis James, Global Director of Clinical Affairs | Interscope, Inc. | 508-847-9478 | alexis.james@interscopemed.com |
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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 | Apr 19, 2019 | Aug 31, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
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| Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit. | 90-day follow-up visit |
| Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). | 90-day follow-up visit |
| Angers |
| France |
| Hopital Edouard Herriot | Lyon | 69003 | France |
| Cochin University Hospital | Paris | 75014 | France |
| Allgemeines Krankenhaus Celle | Celle | 29223 | Germany |
| Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf | Hamburg | Germany |
| Catholic Clinic Mainz | Mainz | Germany |
| Sana Klinikum Offenbach | Offenbach | 63069 | Germany |
| Fondazione Poliambulanza Istituto Ospedaliero | Brescia | 25124 | Italy |
| Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica | Rome | 00168 | Italy |
| Humanitas Research Hospital & Humanitas University | Rozzano | 20089 | Italy |
| PI left center and never scheduled 90 day follow-up visit. |
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| 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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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Primary | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | The safety analysis will be completed on all subjects who were treated with the EndoRotor device. | Posted | Number | Serious Adverse Events | Index Procedure through 90 Day Post Procedure Follow-up Visit |
|
|
|
| Secondary | Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. | Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit. | Posted | Count of Participants | Participants | Index Procedure |
|
|
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| Secondary | Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. | Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit. | Posted | Count of Participants | Participants | 90-day follow-up visit |
|
|
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| Secondary | Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit. | Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit. | Posted | Count of Participants | Participants | 90-day follow-up visit |
|
|
|
| Secondary | Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). | Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit. | Posted | Count of Units | Specimens | 90-day follow-up visit | Specimens | Specimens |
|
|
|
| 1 |
| 66 |
| 7 |
| 66 |
| 6 |
| 66 |
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| Delayed Rectal Bleed | Injury, poisoning and procedural complications | Systematic Assessment | Onset: Post Procedure / After Discharge Severity: Mild / Mild Relation EndoRotor: Possible / Probable Relation Procedure: Both Probable Action Taken: Both Hospitalization, observation, no intervention needed Outcome: Both Recovered |
|
| Single Arterial Bleed | Gastrointestinal disorders | Systematic Assessment | Onset: Procedure Severity: Severe Relationship EndoRotor: Not Related Relationship Procedure: Related Action Taken: clips and hospitalization Outcome: recovered |
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| Delayed Bleeding | Gastrointestinal disorders | Systematic Assessment | Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Mediation, hospitalization, endoscopic hemostasis Recovered |
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| General Infection | Infections and infestations | Systematic Assessment | Onset: after discharge prior to 90 day follow-up Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Possible Action taken: Hospitalization and observation Recovered |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Onset: After discharge prior to 90 days Severity: Mild Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Hospitalization Recovered |
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| Heart Attack | Cardiac disorders | Systematic Assessment | Onset: After discharge prior to 90 days Severity: Severe Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: None Outcome: Death |
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| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment | Onset: Post procedure prior to discharge Severity: mild Relationship to EndoRotor: not related Relationship to Procedure: not related Action: Medication Recovered |
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| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment | Onset: Both Procedure Severity: Both mild Relationship to EndoRotor: Possible / Related Relationship to Procedure: Possible / Related Action: Hot biopsy / Clip Both recovered |
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| Seeping bleed | Injury, poisoning and procedural complications | Systematic Assessment | Onset: both procedure Severity: both mild Relationship to EndoRotor: both related Relationship to Procedure: both not related Action: both clips Both Recovered |
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| Single Arterial Bleed Severe Relation to EndoRotor: Not related Relation to Proc. Not related |
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| General Infection Moderate Relation to EndoRotor: Not related Relation to Proc. Not related |
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