Seal-G / Seal-G MIST Study

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532515
• Other study ID #: DLG-072-06
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: Advanced Medical Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 30, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center (Tel Hashomer)	Ramat Gan
Israel	Shamir (Assaf Harofeh) Medical Center	Rishon LeZion

Sponsors (3)

Lead Sponsor	Collaborator
Advanced Medical Solutions Ltd.	Advanced Medical Solutions Israel (Sealantis) Ltd., ClinSearch

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital length of stay	Measured by the time for "Ready to be discharged" (in days)	Up to 30 days post-surgery