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New treatment option for Anastomotic Leaks
Official title Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
ClinicalTrials.gov ID: NCT07035431
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Weston, Florida, United States
- Burlington, Massachusetts, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Huntington, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Weston, Florida, United States; Burlington, Massachusetts, United States; New York, New York, United States; Cleveland, Ohio, United States; Hershey, Pennsylvania, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.