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RECRUITING NA

Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

NCT07035431 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 66 participants
Start Date 2026-03
Est. Completion 2028-12
Phase NA

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07035431

The ClinicalTrials.gov registry entry for NCT07035431 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07035431 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Pennsylvania, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07035431?

The interventions under investigation include: Endo-SPONGE (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07035431?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial