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
|Condition or disease||Intervention/treatment||Phase|
|Elective Surgical Procedures, Digestive System||Device: Seal-G||Not Applicable|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
A surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques
Other Name: Seal-G Surgical Sealant
- Rate of device related complications [ Time Frame: Postoperative to end of follow up (30±7 days) ]
- Overall rate of complications [ Time Frame: Postoperative to end of follow up (30±7 days) ]
- Postoperative length of hospitalization stay [ Time Frame: Postoperative till time for "ready to be discharged" (10±4 days) ]
- Duration of sealant application [ Time Frame: Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes) ]
- 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.
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
|Rabin Medical Center|
|Petah Tikva, Israel|
|Humanitas Research Hospital|
|Rozzano Milano, Italy|
|Study Director:||Rina Lev, PhD||Sealantis Ltd.|