Trials / Recruiting
RecruitingNCT07035431
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endo-SPONGE | The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-06-25
- Last updated
- 2026-04-08
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07035431. Inclusion in this directory is not an endorsement.