Trial Outcomes & Findings for EndoRotor® Endoscopic Mucosal Resection System for the Colon (NCT NCT04203667)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Index Procedure through 90 Day Post Procedure Follow-up Visit

Results posted on

2022-04-05

Participant Flow

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.

The study was over-enrolled. The protocol required 60 subjects; however, 66 subjects were enrolled and treated of which 62 completed the study.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	66
Overall Study Per Protocol Population	45
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1
Overall Study Death	1
Overall Study PI left center and never scheduled 90 day follow-up visit.	1

Baseline Characteristics

EndoRotor® Endoscopic Mucosal Resection System for the Colon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EndoRotor Resection Arm n=66 Participants 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.
Age, Continuous	69 Years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	49 Participants n=5 Participants
Race/Ethnicity, Customized Not Disclosed	16 Participants n=5 Participants
Race/Ethnicity, Customized African/Black	1 Participants n=5 Participants
Height	168.2 cm STANDARD_DEVIATION 10.0 • n=5 Participants
Weight	76.1 kg STANDARD_DEVIATION 17.6 • n=5 Participants
Systolic Blood Pressure	135.6 mmHg STANDARD_DEVIATION 25.2 • n=5 Participants
Diastolic Blood Pressure	76.1 mmHg STANDARD_DEVIATION 11.6 • n=5 Participants

PRIMARY outcome

Timeframe: Index Procedure through 90 Day Post Procedure Follow-up Visit

Population: 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.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=45 Participants 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.
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.	45 Participants

PRIMARY outcome

Timeframe: Index Procedure through 90 Day Post Procedure Follow-up Visit

Population: The safety analysis will be completed on all subjects who were treated with the EndoRotor device.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=66 Participants 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.
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. Total number of serious adverse events in Intent to Treat Population.	5 Serious Adverse Events
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. Delayed Rectal Bleed both mild Relation EndoRotor: probable/possible Relation Proc: Both probable	2 Serious Adverse Events
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. Mucosal Laceration Severe Relation to EndoRotor: Unlikely Relation to Procedure: Possible	1 Serious Adverse Events
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. Single Arterial Bleed Severe Relation to EndoRotor: Not related Relation to Proc. Not related	1 Serious Adverse Events
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. General Infection Moderate Relation to EndoRotor: Not related Relation to Proc. Not related	1 Serious Adverse Events

SECONDARY outcome

Timeframe: Index Procedure

Population: 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.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=45 Participants 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.
Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.	45 Participants

SECONDARY outcome

Timeframe: 90-day follow-up visit

Population: 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.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=47 Participants 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.
Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.	0 Participants

SECONDARY outcome

Timeframe: 90-day follow-up visit

Population: 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.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=45 Participants 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.
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.	21 Participants

SECONDARY outcome

Timeframe: 90-day follow-up visit

Population: 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.

Outcome measures

Outcome measures
Measure	EndoRotor Resection Arm n=45 Specimens 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.
Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).	45 Specimens

Adverse Events

EndoRotor Resection Arm

Serious events: 7 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	EndoRotor Resection Arm n=66 participants at risk 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.
Injury, poisoning and procedural complications Mucosal Laceration	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Injury, poisoning and procedural complications Delayed Rectal Bleed	3.0% 2/66 • Number of events 2 • Index procedure through the 90 day post procedure follow-up visit.
Gastrointestinal disorders Single Arterial Bleed	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Gastrointestinal disorders Delayed Bleeding	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Infections and infestations General Infection	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Infections and infestations Urinary Tract Infection	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Cardiac disorders Heart Attack	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.

Other adverse events

Other adverse events
Measure	EndoRotor Resection Arm n=66 participants at risk 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.
Gastrointestinal disorders Post Polypectomy Syndrome	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Musculoskeletal and connective tissue disorders Headache	1.5% 1/66 • Number of events 1 • Index procedure through the 90 day post procedure follow-up visit.
Injury, poisoning and procedural complications Bleeding	3.0% 2/66 • Number of events 2 • Index procedure through the 90 day post procedure follow-up visit.
Injury, poisoning and procedural complications Seeping bleed	3.0% 2/66 • Number of events 2 • Index procedure through the 90 day post procedure follow-up visit.

Additional Information

Alexis James, Global Director of Clinical Affairs

Interscope, Inc.

Phone: 508-847-9478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place