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NCT Number: NCT07100886

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.

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Key information

Conditions

Colon Anastomosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)
  • Control Group: comparable retrospective subjects that meet the same inclusion criteria specified in #DLG-072-06.
  • Both Treatment & Control group:

Willing to comply with long-term follow-up assessment (including oral consent).

Exclusion criteria

  • Both Treatment & Control group:

Patients who are unable or unwilling to complete the phone questionnaire.

  • Control group: Subjects that would have been excluded according to the previous PMCF study #DLG-072-06 exclusion criteria.
  • 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.

Treatment and study plan

long-term follow up visit

Other

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

Primary outcomes

  1. Rate of reoperation due to anastomotic complications

    Time frame: 1 year post-surgery

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

    Time frame: 1 year post-surgery

    At least one complication within the 1 year interval

Secondary outcomes

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

    Time frame: 1-4 years post-surgery

  2. The incidence of hospitalization due to anastomotic complications

    Time frame: 1-4 years post-surgery

  3. The incidence of reoperation due to anastomotic complications

    Time frame: 1-4 years post surgery

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

    Time frame: 30 day post surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Naama Giwnewer, Clinical Manager

CONTACT

[email protected]

+972506979691

Sponsors and collaborators

Lead sponsor

Advanced Medical Solutions Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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