NCT03694210

EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Interscope, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatic Necrosis
• Acute Pancreatitis
• Necrotizing Pancreatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2018-10-03
• Last updated: 2021-11-02
• Results posted: 2021-11-02

Locations

10 sites across 3 countries: United States, Germany, Netherlands

Regulatory

• FDA-regulated device study