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

NCT07100886 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 208

Last updated 2025-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Colon Anastomosis

Interventions

OTHER

long-term follow up visit

Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm

Sponsors & Collaborators

  • Advanced Medical Solutions Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2025-11-30
Completion
2026-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100886 on ClinicalTrials.gov