Seal-G / Seal-G MIST Study
- Conditions
- Gastrointestinal CancerColon Cancer
- Interventions
- Device: Seal-G Surgical SealantDevice: Seal-G MIST System
- Registration Number
- NCT04532515
- Lead Sponsor
- Advanced Medical Solutions Ltd.
- Brief Summary
A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery
- Detailed Description
Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate based sealant technology and intended purpose. The devices only differ in their method of application, The Seal-G device is designed for spread application by extra-corporal approach, and the Seal-G MIST device is designed for spray application by intra-corporal approach.
The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
- Subject is aged 18 years to 80 years
- Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)
- Anastomosis is expected to be ≤ 10cm from anal verge
- Surgery involves stoma creation
- Subject who underwent a prior pelvic radiation therapy
- Subject with a BMI > 40 or <19
- Subject with ASA status higher than 3
- Albumin level < 3 gr/dl
- Total bilirubin >1.5 mg/dL
- Hemoglobin level < 8mg/dl on day of surgery
- 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 within 6 months from surgery, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection, uncontrolled DM with episodes of hospitalization due to hypo or hyperglycemia within 6 months of surgery)
- Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
- Subject with known sensitivity to Indigo carmine dye (FD&C 2/ E132)
- Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
- Subject requires more than one anastomosis during the surgery
- Subject is scheduled for another surgery during the follow up period of this study
- Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)
Intraoperative Exclusion Criteria:
Subjects who meet any of the following intra-operative exclusion criteria will be considered as screen failures and will not be eligible for the study:
- Positive leak test requires anastomosis takedown and/or re-anastomosis.
- Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
- Subjects whom anastomosis is ≤10 cm from the anal verge
- Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
- Subject received two or more units of PC transfusion during surgery
- Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Seal G / Seal-G MIST Seal-G Surgical Sealant Seal-G Surgical Sealant \[Seal-G\]- will be applied on colonic anastomosis created by extra-corporal approach. Seal-G MIST System \[Seal-G MIST\]- will be applied on colonic anastomosis created by intra-corporal approach. Seal G / Seal-G MIST Seal-G MIST System Seal-G Surgical Sealant \[Seal-G\]- will be applied on colonic anastomosis created by extra-corporal approach. Seal-G MIST System \[Seal-G MIST\]- will be applied on colonic anastomosis created by intra-corporal approach.
- Primary Outcome Measures
Name Time Method Proportion of surgeries with full sealant coverage - successful application At time of surgery 1- The surgeon applied the sealant over the full circumference of the anastomosis (successful application).
0 - The surgeon did not fully cover the anastomosis circumference
- Secondary Outcome Measures
Name Time Method Hospital length of stay Up to 30 days post-surgery Measured by the time for "Ready to be discharged" (in days)
Proportion of subjects with subclinical / radiological leaks Up to 30 days post-surgery 1 - The subject had a Subclinical /radiological anastomotic leak 0 - The subject did not have a Subclinical /radiological anastomotic leak
Proportion of subjects with clinical anastomotic leaks Up to 30 days post-surgery 1 - The subject had a clinical anastomotic leak 0 - The subject did not have a clinical anastomotic leak
Proportion of subjects with at least one Serious Adverse Event Up to 30 days post-surgery 1 - The subject had any Serious adverse event 0 - The subject did not have Serious adverse event
Proportion of subjects that had a reoperation Up to 30 days post-surgery 1 - The subject had any event of reoperation 0 - The subject did not have reoperation
Trial Locations
- Locations (2)
Shamir (Assaf Harofeh) Medical Center
🇮🇱Rishon LeZion, Israel
Sheba Medical Center (Tel Hashomer)
🇮🇱Ramat Gan, Israel