N/A
N=37
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
Acute Pancreatic Necrosis · Acute Pancreatitis · Necrotizing Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT03694210 ↗Enrolled (actual)
37
Serious AEs
30.0%
Results posted
Nov 2021
Primary outcome: Primary: Safety: Number of Participants With Device Related Complications — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EndoRotor Therapy (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Interscope, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With Device Related Complications |
— | — |
| SECONDARY Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed |
29 | — |
| SECONDARY Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis |
117; 71 | — |
| SECONDARY Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. |
60 | — |
| SECONDARY Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis. |
2 | — |
| SECONDARY Mean Length of Hospital Stay Per Participant |
18 | — |
| SECONDARY Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score |
36.0; 57.3; 11.4; 25.0; 27.8; 51.4 | 0.0011 sig |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03694210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.