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

NCT07100886 | Not Yet Recruiting

• 1 other identifier: DLG-072-13
• Study Type: observational
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Rate of reoperation due to anastomotic complications

  1 year post-surgery

• Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)

  At least one complication within the 1 year interval

  1 year post-surgery

Secondary Outcomes (4)

• The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)

  1-4 years post-surgery

• The incidence of hospitalization due to anastomotic complications

  1-4 years post-surgery

• The incidence of reoperation due to anastomotic complications

  1-4 years post surgery

• The incidence of anastomotic leaks (Clinical/sub-clinical)

  30 day post surgery

Study Arms (2)

Retrospective Treatment Group

Patients who underwent colectomy and anastomosis coverage with Seal-G / Seal-G MIST as part of the previous PCMF study protocol (#DLG-072-06)

Other: long-term follow up visit

Retrospective Control Group

Patients who underwent colon resection with primary anastomosis (SOC) (comparable population)

Other: long-term follow up visit

Interventions

long-term follow up visit OTHER

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

Retrospective Control Group; Retrospective Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)
• Both Treatment \& Control group:
• Willing to comply with long-term follow-up assessment (including oral consent).

You may not qualify if:

• Both Treatment \& Control group:
• Patients who are unable or unwilling to complete the phone questionnaire.
• Patients with missing or incomplete medical records that prevent retrospective comparison.
• Patients that during the original surgery received any treatment on the anastomosis (sealant/glue) except for the anastomosis closure technique (sutures/staple).
• Original surgery included stoma creation.

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

Central Study Contacts

Naama Giwnewer, Clinical Manager

CONTACT

+972506979691; naamag@admedsol.co.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 4, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07