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Seal-G / Seal-G MIST Study | Clinical Trials | Clareo Health

COMPLETEDNA

Seal-G / Seal-G MIST Study

Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection

NCT04532515•Advanced Medical Solutions Ltd.

View on ClinicalTrials.gov

Summary

A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery

Detailed Description

Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate based sealant technology and intended purpose. The devices only differ in their method of application, The Seal-G device is designed for spread application by extra-corporal approach, and the Seal-G MIST device is designed for spray application by intra-corporal approach. The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
•2. Subject is aged 18 years to 80 years
•3. Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)

Exclusion Criteria

•1. Anastomosis is expected to be ≤ 10cm from anal verge
•2. Surgery involves stoma creation
•3. Subject who underwent a prior pelvic radiation therapy
•4. Subject with a BMI \> 40 or \<19
•5. Subject with ASA status higher than 3
•6. Albumin level \< 3 gr/dl
•7. Total bilirubin \>1.5 mg/dL
•8. Hemoglobin level \< 8mg/dl on day of surgery
•9. Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
•10. Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
+13 more criteria

Locations (2)

Sheba Medical Center (Tel Hashomer)

Ramat Gan, Israel

Shamir (Assaf Harofeh) Medical Center

Rishon LeZiyyon, Israel

Key Dates

Start Date

February 1, 2021

Primary Completion Date

July 25, 2023

Completion Date

October 30, 2023

Last Updated

December 11, 2023

Enrollment

160

ACTUAL participants

Conditions

Colon CancerGastrointestinal Cancer

Interventions

Seal-G Surgical Sealant

DEVICE

Seal-G MIST System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Seal-G / Seal-G MIST Study

Inclusion Criteria

Exclusion Criteria

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