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NCT07035431 · ClinicalTrials.gov registry record · NA
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
A NA study of Anastomotic Leaks and Hartmanns Stump Leakage, sponsored by Boston Scientific Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 6
- Study locations
NCT07035431: Recruiting NA study of Anastomotic Leaks and Hartmanns Stump Leakage, sponsored by Boston Scientific Corporation.
NCT07035431 is a NA study of Anastomotic Leaks and Hartmanns Stump Leakage that is actively recruiting participants, run by Boston Scientific Corporation. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07035431, a NA study of Anastomotic Leaks and Hartmanns Stump Leakage, is actively recruiting participants, sponsored by Boston Scientific Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
The proportion of subjects with one or more study device or endoscopic or study procedure-related Serious Adverse Events (SAEs) occurring up to 3 months after the last study device removal.
Conditions Studied
Interventions
- DEVICE Endo-SPONGE
Study Locations (6)
Pennsylvania
- Penn State Health - Hershey
- Thomas Jefferson University Hospital - Philadelphia
New York
- Mount Sinai - New York
Ohio
- Ohio State University Medical Center - Columbus
Washington
- University of Washington Medical Center - Seattle
West Virginia
- Marshall University Medical Center - Huntington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-03 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT07035431 shows while recruiting
NCT07035431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Anastomotic Leaks appearing as the primary indexed condition, and to 1 intervention - of which Endo-SPONGE is the first listed.
NCT07035431 lists 6 locations in 5 states (Pennsylvania, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT07035431 about?
NCT07035431 is a clinical study titled "Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area". 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.
What is the current status of trial NCT07035431?
This trial is currently recruiting. It is a NA study. The enrollment target is 66 participants. The study started on 2026-03. Estimated completion is 2028-12.
What conditions does trial NCT07035431 study?
This clinical trial studies the following conditions: Anastomotic Leaks, Hartmanns Stump Leakage.
What interventions are being tested in trial NCT07035431?
The interventions under investigation include: Endo-SPONGE (DEVICE).
Who is sponsoring clinical trial NCT07035431?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07035431 being conducted?
This trial has 6 study locations across New York, Ohio, Pennsylvania, Washington, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07035431's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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