Seal-G/ Seal-G MIST Long-Term Follow-up PMCF (Continue) Study

Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness. This continuation study aims to evaluate the long-term impact of the SEAL-G/MIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.

NCT Number	NCT07100886
Lead Sponsor	Advanced Medical Solutions Ltd.
Conditions	Colon Anastomosis
Enrollment	208 participants
Start Date	2025-08-04
Primary Completion	2025-11-30 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-03