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

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

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Device: Seal-G Surgical Sealant; Device: Seal-G MIST System

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naama Giwnewer; Phone Number: +972.4.8291033; Email: naamag@admedsol.co.il
• Study Contact Backup: Name: Susan Clark; Email: susan.clark@admedsol.com

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center (Tel HaShomer)
  • Rishon LeZion, Israel
    • Shamir (Assaf Harofeh) Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)
11. Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction within 6 months from surgery, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection, uncontrolled DM with episodes of hospitalization due to hypo or hyperglycemia within 6 months of surgery)
12. Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
13. Subject with known sensitivity to Indigo carmine dye (FD&C 2/ E132)
14. Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
15. Subject requires more than one anastomosis during the surgery
16. Subject is scheduled for another surgery during the follow up period of this study
17. Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)

Intraoperative Exclusion Criteria:

Subjects who meet any of the following intra-operative exclusion criteria will be considered as screen failures and will not be eligible for the study:

1. Positive leak test requires anastomosis takedown and/or re-anastomosis.
2. Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
3. Subjects whom anastomosis is ≤10 cm from the anal verge
4. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
5. Subject received two or more units of PC transfusion during surgery
6. Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Seal G / Seal-G MIST; Seal-G Surgical Sealant [Seal-G]- will be applied on colonic anastomosis created by extra-corporal approach. Seal-G MIST System [Seal-G MIST]- will be applied on colonic anastomosis created by intra-corporal approach.

Device: Seal-G Surgical Sealant; Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis; Other Names: Seal-G; Device: Seal-G MIST System; Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis; Other Names: Seal-G MIST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of surgeries with full sealant coverage - successful application	1- The surgeon applied the sealant over the full circumference of the anastomosis (successful application). 0 - The surgeon did not fully cover the anastomosis circumference	At time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with clinical anastomotic leaks	1 - The subject had a clinical anastomotic leak 0 - The subject did not have a clinical anastomotic leak	Up to 30 days post-surgery
Proportion of subjects with subclinical / radiological leaks	1 - The subject had a Subclinical /radiological anastomotic leak 0 - The subject did not have a Subclinical /radiological anastomotic leak	Up to 30 days post-surgery
Proportion of subjects with at least one Serious Adverse Event	1 - The subject had any Serious adverse event 0 - The subject did not have Serious adverse event	Up to 30 days post-surgery
Proportion of subjects that had a reoperation	1 - The subject had any event of reoperation 0 - The subject did not have reoperation	Up to 30 days post-surgery
Hospital length of stay	Measured by the time for "Ready to be discharged" (in days)	Up to 30 days post-surgery

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Collaborators: ClinSearch; Advanced Medical Solutions Israel (Sealantis) Ltd.
• Investigators: Study Director: Moshe Kamar, MD, Advanced Medical Solutions Israel (Sealantis) Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: DLG-072-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No