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Seal-G Safety Study

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ClinicalTrials.gov Identifier: NCT02825173
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sealantis Ltd.

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.

Condition or disease Intervention/treatment Phase
Elective Surgical Procedures, Digestive System Device: Seal-G Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis
Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2, 2016

Arm Intervention/treatment
Experimental: Seal-G
A surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device: Seal-G

Intervention:

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

Other Name: Seal-G Surgical Sealant




Primary Outcome Measures :
  1. Rate of device related complications [ Time Frame: Postoperative to end of follow up (30±7 days) ]

Secondary Outcome Measures :
  1. Overall rate of complications [ Time Frame: Postoperative to end of follow up (30±7 days) ]
  2. Postoperative length of hospitalization stay [ Time Frame: Postoperative till time for "ready to be discharged" (10±4 days) ]
  3. Duration of sealant application [ Time Frame: Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes) ]
  4. Ease of use of the device [ Time Frame: Intraoperative: device application ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825173


Locations
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Israel
Rabin Medical Center
Petah Tikva, Israel
Assaf Harofeh
Tzrifin, Israel
Italy
Humanitas Research Hospital
Rozzano Milano, Italy
Sponsors and Collaborators
Sealantis Ltd.
Investigators
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Study Director: Rina Lev, PhD Sealantis Ltd.
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Responsible Party: Sealantis Ltd.
ClinicalTrials.gov Identifier: NCT02825173    
Other Study ID Numbers: DLG-072-01
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided