Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study] (SEALAR)
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|ClinicalTrials.gov Identifier: NCT03448874|
Recruitment Status : Withdrawn (The company will design a new study)
First Posted : February 28, 2018
Last Update Posted : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Diverticulitis Colon||Device: Seal-G MIST System||Not Applicable|
- Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Once potential eligibility to the study is determined based on the study's inclusion/exclusion criteria, study procedures will be explained to the candidate and participation will be offered.
- Informed consent process.
- Pre-surgery assessments will be according to the routine practice at the site and determined by the treating physician.
- During the surgery, after confirmation of the intra-operative exclusion criteria, completion of anastomosis creation and only after leak test was performed , subjects will be allocated to one of the two treatment arms with a 1:1 ratio based on a randomization scheme (either to the Standard of care (SOC) or to Seal-G MIST arms).
- Device (Seal-G MIST System) application (to Seal-G MIST treatment arm only).
- Subjects will be followed during post-operative period until discharge from the hospital for clinical and subclinical leaks according to the SOC.
- In an event of suspected anastomotic leak, patient will be treated according to severity of leak and PI clinical judgement (conservative treatment, drainage, diversion, anastomosis take down).
Subjects will be followed up for leaks and related AE/SAEs at the day of the surgery and for a period of 15 weeks (±2 weeks) post-surgery, including the following activities:
- Daily while hospitalized (in accordance with the site routine procedures)
- At 1 month (±1 week) and 15 weeks (±2 weeks) post-surgery (Hospitalization for elective procedure (i.e. chemotherapy treatments) will not be considered as SAEs)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Controlled, Randomized, single blind study|
|Masking Description:||This study is single blinded. The subject will be blinded to the treatment arm; however, by nature of the type of the proposed study, blinding of the investigator/ surgeon is not feasible. In order to minimize bias, subjects will be randomized during the surgery upon confirmation of the intra-operative exclusion criteria. This will ensure that the surgeon will not know prior to surgery and until completion of anastomosis creation, whether or not Seal-G MIST will be used.|
|Official Title:||Seal-G MIST System Safety Study [SEALAR Study]|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Seal-G MIST System
Seal-G MIST System is a surgical sealant that will be applied adjunctively to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device: Seal-G MIST System
Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.
Other Name: Seal-G MIST
No Intervention: Standard of care
Patients in the control arm will receive the standard of care [SOC] for colorectal resection surgery with primary anastomosis (no additional intervention)
- Incidence of overall subject pre-specified* procedure related Adverse Events [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]Pre-specified procedure related Adverse Event: Wound infection; Bowel obstruction and Post-operative ileus; Anastomotic stricture; Anastomotic leak; Collection/Abscess; Urinary retention/Urinary Tract Infection; Renal failure; Hepatic failure; Peritoneal metastasis; Staple-line bleeding; Allergic reaction; Re-intervention (Including but not limited to re-operation; stoma).
- Incidence of clinical anastomotic leaks [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]Anastomotic leak (AL) is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to local or general peritonitis, abscesses in the proximity of the anastomosis and/or fistula, fecal or purulent discharge from drains.
- Incidence of subclinical/ radiological leaks [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]As assessed from Adverse event/Serious Adverse Event reporting form
- Incidence of Serious Adverse Events (SAE) complications [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]According to Serious Adverse Event (SAE) definition from Medical Device Directive (MEDDEV 2.7/3, Rev 3, May 2015)
- Incidence of collection/abscess without demonstrated leak [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]According to Adverse event reporting form
- Incidence of reoperation [ Time Frame: up to 30 days post-surgery ]According to Adverse event/Serious Adverse Event reporting form
- Incidence of postoperative mortality [ Time Frame: up to 15 weeks (±2 weeks) ]
- Hospital length of stay [ Time Frame: From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days ]
- Incidence of "deployment failure" [ Time Frame: during surgery ]only for treatment arm
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): NCT03448874
|Study Director:||Moshe Kamar, MD||Chief Medical Officer|