NCT07100886

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

Long-Term Safety and Efficacy Evaluation of Seal-G and Seal-G MIST Surgical Sealants for Anastomosis Protection in Colon Surgery [PMCF Study Continuation]

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 208 (estimated)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed as an observational, retrospective-controlled, long-term follow-up, multi-center post-market clinical follow-up (PMCF) study. For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures. For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment. Phone Questionnaire: Long-term follow-up visit should be performed via Phone call Questionnaire. Patients will be contacted (including Oral informed consent) to assess long-term outcomes relating to the colon anastomosis surgery they underwent 2-4 years ago. * Incidence of adhesions, stenosis, and obstruction (reported during the Physician questionnaire and confirmed by medical records review where possible). * Need for reoperation due to complications. * Use of additional treatments relating to anastomosis complications (e.g., anti-adhesion therapy, bowel obstruction management).

Conditions

• Colon Anastomosis

Interventions

Type	Name	Description
OTHER	long-term follow up visit	Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm

Timeline

• Start date: 2025-08-04
• Primary completion: 2025-11-30
• Completion: 2026-01-30
• First posted: 2025-08-03
• Last updated: 2025-08-03