Seal-G / Seal-G MIST Study

Advanced Medical Solutions

Status: Completed

Conditions: Gastrointestinal Cancer; Colon Cancer

Treatments: Device: Seal-G Surgical Sealant; Device: Seal-G MIST System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04532515

DLG-072-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)
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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Seal G / Seal-G MIST

Experimental group

Description:

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.

Treatment:

Device: Seal-G MIST System

Device: Seal-G Surgical Sealant