EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

November 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Rate of major complications[ Time Frame: 21 +/- 7 Days ]

The primary endpoint of this study is the freedom from major 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Effectiveness: Percentage of necrosis removed measured by CT Scan[ Time Frame: 21 +/- 7 Days ]
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 day follow up visit.
Procedure Time: Record each procedure time[ Time Frame: 14 Days ]
Assessment of total procedure time to achieve clearance of necrosis for all procedures.
Adequacy of Procedural Debridement: Visual estimation of percent removal of necrosis from the site based on endoscopic view[ Time Frame: 14 Days ]
At conclusion of the procedure, the percent removal of the total necrosis present will be visually estimated by the Investigator as a measure of removal adequacy with the EndoRotor
Number of Procedures: Record total number of procedures to achieve clearance[ Time Frame: 14 Days ]
Assessment of total number of procedures to achieve clearance of necrosis.
Hospital Resource Utilization: Total length of hospital stay[ Time Frame: 21 +/- 7 Days ]
The total length of hospital stay measured from the first use of the EndoRotor to study exit at the 21 day follow up visit will be used to determine potential economic advantages of the EndoRotor procedure.
Quality of Life - SF-36v2 Health Survey, Physical Composite Score[ Time Frame: 21 +/- 7 Days ]
Evaluation of Physical Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50
Quality of Life - SF-36v2 Health Survey, Mental Composite Score[ Time Frame: 21 +/- 7 Days ]
Evaluation of Mental Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50

Descriptive Information

Brief Title ^ICMJE

EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

Official Title ^ICMJE

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

Brief Summary

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention 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: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 15, 2018

Estimated Primary Completion Date

November 15, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Subjects who are >22; inclusive of males and females. 2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage 3. Imaging suggestive of greater than or equal to 30% necrotic material 4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm 5. Subject can tolerate repeated endoscopic procedures 6. Subject capable of giving informed consent. 7. 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: 1. Subject unable to give informed consent. 2. Subject is unwilling to return for repeated endoscopies. 3. Documented Pseudoaneurysm > 1cm within the WOPN 4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). 5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 6. 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). 7. 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. 8. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Sex/Gender

Sexes Eligible for Study:

All

Ages

22 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Germany|Netherlands|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Interscope, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Marco Bruno, MD PhD Erasmus Medical Center

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名