Endo-SPONGE treatment for lower pelvic anastomotic or Hartmann's stump leakages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter interventional study using sponge-based endoscopic vacuum therapy (Endo-SPONGE) to treat anastomotic or Hartmann's stump leakages in the lower pelvic area. Adults with confirmed grade B leaks, an extraperitoneal transmural defect of at least 2 cm, and a diverting ostomy are eligible and will undergo endoscopic placement of the sponge with serial exchanges until defect closure. The study will collect safety data and effectiveness outcomes such as leak closure rate, time to closure, and procedure-related adverse events. Procedures are performed at participating US centers with protocol-defined follow-up visits to document healing and complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery.
* Subject is eligible for endoscopic intervention.
* Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area.
* Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity.
* Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement.
* Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.
* Investigator decision that EVT is the most suitable treatment of the available treatment options.

Exclusion Criteria:

* Subject is under 18 years of age.
* Potentially vulnerable subject, including, but not limited to pregnant women.
* Subject has undergone EVT or other similar interventions for the current colorectal indication.
* Subject had colorectal surgery more than 60 days prior to the planned study procedure.
* Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement.
* Subject has known contraindication for EVT as per the IB.
* Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

Where it's running

• Mount Sinai
  New York, New York, United States Recruiting
• Penn State Health
  Hershey, Pennsylvania, United States Recruiting
• University of Washington Medical Center
  Seattle, Washington, United States Recruiting
• Marshall University Medical Center
  Huntington, West Virginia, United States Recruiting
• University of California, Davis Medical Center
  Sacramento, California, United States Not yet recruiting
• Orlando Regional Medical Center
  Orlando, Florida, United States Not yet recruiting

Study contacts

• Principal investigator: Eric Pauli, MD — Penn State Health
• Study coordinator: Steve Fodem
• Email: Steve.Fodem@bsci.com
• Phone: 651-246-3094

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biological mesh reinforcement for digestive tract reconstruction

  This study tests whether inserting a biological mesh during alimentary tract reconstruction can reduce bleeding and complications after digestive surgery.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07921732

• Predicting bowel leaks after colorectal surgery with a computer model and surgeon input

  This study tests a computer model that predicts anastomotic leaks after colorectal surgery, and sees if adding surgeons’ intuition improves the predictions.

  Recruiting at 2 sites University Hospital, Basel, Switzerland · Liestal, Basel-Landschaft and 1 other locations · NCT07888478

• Signia circular stapler for left-sided colon, sigmoid, and rectal resections

  This study will try the Signia circular stapler with Tri-Staple technology to see if it safely creates bowel reconnections in adults having left-sided colon, sigmoid, or rectal surgery.

  Recruiting at 6 sites Medtronic - MITG · New Haven, Connecticut and 9 other locations · NCT07351071

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.