EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

EndoRotor Therapy

About this trial

This is an interventional treatment trial for Acute Pancreatic Necrosis focused on measuring Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who are >22; inclusive of males and females.
Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
Imaging suggestive of greater than or equal to 30% necrotic material
Walled off pancreatic necrosis size ≥6 cm and ≤22cm
Subject can tolerate repeated endoscopic procedures
Subject capable of giving informed consent.
Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.

Exclusion Criteria:

Subject unable to give informed consent.
Subject is unwilling to return for repeated endoscopies.
Documented Pseudoaneurysm > 1cm within the WOPN
Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoRotor Therapy

Arm Description

Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.

Outcomes

Primary Outcome Measures

Safety: Number of Participants With Device Related Complications

The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.

Secondary Outcome Measures

Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed

Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit.

Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis

Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.

Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.

At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.

Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.

The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.

Mean Length of Hospital Stay Per Participant

The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.

Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score

The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.

Full Information

NCT ID

NCT03694210

First Posted

September 26, 2018

Last Updated

October 4, 2021

Sponsor

Interscope, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03694210

Brief Title

EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

Official Title

Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

August 22, 2019 (Actual)

Study Completion Date

August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Interscope, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).

Detailed Description

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US. Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis

Keywords

Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EndoRotor Therapy

Arm Type

Experimental

Arm Description

Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.

Intervention Type

Device

Intervention Name(s)

EndoRotor Therapy

Intervention Description

To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.

Primary Outcome Measure Information:

Title

Safety: Number of Participants With Device Related Complications

Description

The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.

Time Frame

21 +/- 7 Days

Secondary Outcome Measure Information:

Title

Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed

Description

Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit.

Time Frame

21 +/- 7 Days

Title

Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis

Description

Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.

Time Frame

Completion of all necrosectomy procedures per patient

Title

Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.

Description

At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.

Time Frame

This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.

Title

Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.

Description

The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.

Time Frame

This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.

Title

Mean Length of Hospital Stay Per Participant

Description

The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.

Time Frame

At patient discharge from hospital

Title

Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score

Description

The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.

Time Frame

21 +/- 7 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Subjects who are >22; inclusive of males and females. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage Imaging suggestive of greater than or equal to 30% necrotic material Walled off pancreatic necrosis size ≥6 cm and ≤22cm Subject can tolerate repeated endoscopic procedures Subject capable of giving informed consent. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated. Exclusion Criteria: Subject unable to give informed consent. Subject is unwilling to return for repeated endoscopies. Documented Pseudoaneurysm > 1cm within the WOPN Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance). Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Bruno, MD PhD

Organizational Affiliation

Erasmus Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benjamin Tharian

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

California Pacific Medical Center - Sutter Health

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

University of Chicago Department of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Rutgers Robert Wood Johnson Medical School

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Arvin Trindade

City

Queens

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

University of Frankfurt Medicine

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Interdisciplinary Clinic for Endoscopy - TU Munich

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Erasmus Medical Center

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

34562471

Citation

Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.

Results Reference

derived

Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial