Clinical Studies

First-in-Human Trial: Validating Safety and Usability

The First-in-Human study, conducted in June 2023, marked a significant milestone in the clinical development of the ColoSeal ICD System. The trial demonstrated:

✔ Successful implantation and removal of the device in patients undergoing colorectal surgery
✔ No signs of anastomotic leakage, confirming the system’s ability to provide an airtight and fluid-tight seal
✔ Confirmed device functionality in both open and laparoscopic colorectal procedures

These findings validated the ColoSeal ICD System as a safe, reliable, and easily deployable solution for protecting the colorectal anastomosis, reducing the need for temporary ostomies.

Pivotal Clinical Trial: Evaluating Efficacy and Outcomes

Following the success of the First-in-Human study, a Pivotal Clinical Trial was designed to further assess the ColoSeal ICD System’s impact on colorectal surgery recovery. The study includes 180 patients, with a randomized 2:1 trial design, comparing the ColoSeal ICD System against standard ostomy care.

Study Endpoints

The primary endpoint focuses on reducing major post-surgical complications, specifically:

• Anastomotic leakage prevention
• Reduced need for invasive interventions, including ostomy creation
• Lower rates of sepsis, abscess formation, and anastomotic stricture
• Reduced 30-day postoperative morbidity and mortality

Secondary Endpoints Include:

• Reduction in hospital stays and readmission rates
• Patient-reported outcomes on recovery experience
• Cost-effectiveness and reduction in long-term care expenses
• Device performance in various surgical approaches (open, laparoscopic, robotic)

With a 90-day follow-up period, the study aims to provide high-quality clinical data that supports the ColoSeal ICD System’s role in enhancing patient recovery, reducing hospital burden, and improving long-term outcomes incolorectal surgery.

How the ColoSeal ICD System is Transforming Clinical Practice

The ColoSeal ICD System offers a paradigm shift in colorectal surgery by eliminating the need for temporary ostomies in over 90% of cases. Backed by clinical trials, this device is proving to be a safer, more effective alternativefor protecting colorectal anastomoses, helping surgeons achieve better patient outcomes while reducing complications.

✔ Surgeons benefit from a streamlined workflow, minimizing postoperative complications and reoperations.
✔ Patients experience faster recovery, improved quality of life, and a reduced risk of permanent ostomy dependency.
✔ Hospitals and healthcare systems save costs on ostomy-related procedures, hospital stays, and long-term patient care.

The ColoSeal ICD System’s robust clinical evidence supports its potential to become the new standard in colorectal anastomosis protection.