22 and older, any sex, with Acute Pancreatic Necrosis or Acute Pancreatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety: Number of Participants With Device Related ComplicationsPrimary· 21 +/- 7 Days
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.
Group
Value
95% CI
EndoRotor Therapy
0
Effectiveness: Number of Participants With at Least 70% of Necrotic Debris RemovedSecondary· 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 follow up visit.
Group
Value
95% CI
EndoRotor Therapy
29
Mean Total Procedure Time to Achieve at Least 70% Reduction in NecrosisSecondary· Completion of all necrosectomy procedures per patient
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.
Total Procedure Time
Group
Value
95% CI
EndoRotor Therapy
117
± 50
EndoRotor Time
Group
Value
95% CI
EndoRotor Therapy
71
± 37
Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.Secondary· 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.
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%.
Group
Value
95% CI
EndoRotor Therapy
60
± 33
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.Secondary· 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.
The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.
Group
Value
95% CI
EndoRotor Therapy
2
± 2
Mean Length of Hospital Stay Per ParticipantSecondary· At patient discharge from hospital
The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.
Group
Value
95% CI
EndoRotor Therapy
18
± 25
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite ScoreSecondary· 21 +/- 7 Days
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
Physical Functioning
Group
Value
95% CI
Baseline SF-36v1 Score
36.0
± 30.8
21 Day Post Necrosectomy SF-36v1 Score
57.3
± 30.8
Role Limitations due to Physical Health
Group
Value
95% CI
Baseline SF-36v1 Score
11.4
± 28.5
21 Day Post Necrosectomy SF-36v1 Score
25.0
± 37.6
Role Limitations due to Emotional Problems
Group
Value
95% CI
Baseline SF-36v1 Score
27.8
± 41.3
21 Day Post Necrosectomy SF-36v1 Score
51.4
± 48.1
Energy / Fatigue
Group
Value
95% CI
Baseline SF-36v1 Score
27.9
± 22.0
21 Day Post Necrosectomy SF-36v1 Score
36.7
± 23.2
Emotional Well Being
Group
Value
95% CI
Baseline SF-36v1 Score
60.7
± 19.7
21 Day Post Necrosectomy SF-36v1 Score
68.3
± 18.9
Social Functioning
Group
Value
95% CI
Baseline SF-36v1 Score
51.6
± 32.6
21 Day Post Necrosectomy SF-36v1 Score
56.3
± 26.6
Pain
Group
Value
95% CI
Baseline SF-36v1 Score
31.4
± 28.4
21 Day Post Necrosectomy SF-36v1 Score
56.0
± 30.1
General Health
Group
Value
95% CI
Baseline SF-36v1 Score
47.8
± 15.9
21 Day Post Necrosectomy SF-36v1 Score
53.8
± 15.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were captured from Index Procedure through 21 day Follow-up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Interscope, Inc.
Last refreshed: 2 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03694210.