ColoSeal™ ICD System for Rectal Cancer Surgery
This study is testing a new device called the ColoSeal ICD System for people having surgery for rectal cancer. The ColoSeal ICD System is designed to protect the surgical connection (anastomosis) in your colon without needing a temporary ostomy (a surgical opening to divert waste). Researchers want to see if this device can reduce the need for an ostomy and if it's as safe as the current standard treatment, which often includes a protective ostomy. You may be able to join if you are 22-75 years old, have rectal cancer, and meet certain health criteria. The study will look at safety for 270 days and how well the device works after 30 days. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 250 participants. It compares the ColoSeal ICD System to a protective diverting ostomy.
- What's involved
- Subjects will undergo placement of either the ColoSeal ICD Device or a protective diverting ostomy during their surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 270 days, and the effectiveness of the treatment will be assessed after 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
At a glance
Conditions
Where it's being run
9 sites across 6 statesStudy leadership
- Anna Gawlicka, PhD, MBA · STUDY_DIRECTOR · Averto Medical, Inc.
Who to contact
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What this trial measures
- Primary Safety Endpoint270 days
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
- Primary Efficacy Endpoint30 days
Freedom from ostomy creation at 30 days.