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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 3, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07100886
Lead Sponsor Advanced Medical Solutions Ltd.
Conditions
(from sponsor)
Colon Anastomosis
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov