Seal-G Safety Study

Elective Surgical Procedures, Digestive System Clinical Trial

Official title:

A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825173
• Other study ID #: DLG-072-01
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: April 26, 2017
• Start date: August 2016
• Est. completion date: December 2, 2016

Study information

• Verified date: April 2017
• Source: Sealantis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.

Description:

Pre-Surgery:

Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Pre-surgery assessments (after completion of consent process and signed ICF) will be according to the routine practice.

Intra-operative:

During surgery, an assessment of the intra-operative exclusion criteria will be performed. If the subject does not meet any of the exclusion criteria, the subject will be further enrolled. Surgery will be performed according to the site standard of care (routine practice). Anastomosis will be created either using a stapler device (linear or circular), according to manufacture IFU (Instructions for use) or hand suture according to surgeon best practice technique. Once anastomosis has been created, surgeon will verify the anastomosis and mucosal donuts integrity.

Device (Seal-G) application on anastomotic site

Post-operative follow-up: Follow-up evaluations will be performed daily while hospitalized. There will be one postoperative follow up at one month - clinic visit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2, 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is = 18 years old.

2. Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).

3. 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.

Exclusion Criteria:

1. Subject, undergoing low anterior resection

2. Subject is planned to undergo an emergency procedure

3. Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis

4. Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)

5. Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection)

6. Subject who according to the investigator clinical judgement is at risk for anastomosis dehiscence

7. Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days

8. Subject's ASA (American Society of Anesthesiology) score = 4

9. Subject's BMI > 34 or <16

10. Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)

11. Subject with a life expectancy of less than 1 year

12. Subject requires more than one anastomosis during the surgery

13. Woman who is known to be pregnant

14. Mentally handicapped, prisoners, or legally incompetent

Intraoperative Exclusion Criteria:

1. Subjects whom anastomosis is less than 10 cm from the anal verge

2. The full circumference of the anastomosis is not accessible for Seal-G application

3. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G

4. Subject has excessive intraoperative bleeding prior to the anastomosis formation as assessed by the investigator (estimated in excess of 500mL)

5. Subject has peritoneal carcinomatosis

Related Conditions & MeSH terms

• Elective Surgical Procedures, Digestive System

Intervention

Device:
• Seal-G
Intervention: Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva
Israel	Assaf Harofeh	Tzrifin
Italy	Humanitas Research Hospital	Rozzano Milano

Sponsors (1)

Lead Sponsor	Collaborator
Sealantis Ltd.

Countries where clinical trial is conducted

Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of device related complications		Postoperative to end of follow up (30±7 days)
Secondary	Overall rate of complications		Postoperative to end of follow up (30±7 days)
Secondary	Postoperative length of hospitalization stay		Postoperative till time for "ready to be discharged" (10±4 days)
Secondary	Duration of sealant application		Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes)
Secondary	Ease of use of the device	Ease of use of the device will be rated using a Likert scale from 1 to 5 with: 1 being Very easy, 2 Easy, 3 Neutral, 4 Difficult and 5 being Very difficult. At the day of surgery (after surgery completed) the surgeon will complete a questionnaire regarding the device use and ease of application.	Intraoperative: device application