Seal-G Safety Study

NCT02825173 | Completed

• 1 other identifier: DLG-072-01
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Elective Surgical Procedures, Digestive System

Outcome Measures

Primary Outcomes (1)

• Rate of device related complications

  Postoperative to end of follow up (30±7 days)

Secondary Outcomes (4)

• Overall rate of complications

  Postoperative to end of follow up (30±7 days)

• Postoperative length of hospitalization stay

  Postoperative till time for "ready to be discharged" (10±4 days)

• Duration of sealant application

  Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes)

• Ease of use of the device

  Intraoperative: device application

Study Arms (1)

Seal-G

EXPERIMENTAL

A surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.

Device: Seal-G

Interventions

Seal-G DEVICE

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

Also known as: Seal-G Surgical Sealant

Seal-G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years old.
• Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).
• 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.

You may not qualify if:

• Subject, undergoing low anterior resection
• Subject is planned to undergo an emergency procedure
• Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
• Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
• 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)
• Subject who according to the investigator clinical judgement is at risk for anastomosis dehiscence
• Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days
• Subject's ASA (American Society of Anesthesiology) score ≥ 4
• Subject's BMI \> 34 or \<16
• Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
• Subject with a life expectancy of less than 1 year
• Subject requires more than one anastomosis during the surgery
• Woman who is known to be pregnant
• Mentally handicapped, prisoners, or legally incompetent
• Subjects whom anastomosis is less than 10 cm from the anal verge

Sponsors & Collaborators

• Sealantis Ltd.: lead

Study Sites (3)

Rabin Medical Center

Petah Tikva, Israel

Location

Assaf Harofeh

Tzrifin, Israel

Location

Humanitas Research Hospital

Rozzano Milano, Italy

Location

Study Officials

• Rina Lev, PhD

  Sealantis Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: July 7, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 2, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

IL (2); IT (1)