Seal-G / Seal-G MIST Study
Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection
1 other identifier
interventional
160
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedDecember 11, 2023
December 1, 2023
2.5 years
August 26, 2020
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of surgeries with full sealant coverage - successful application
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
At time of surgery
Secondary Outcomes (5)
Proportion of subjects with clinical anastomotic leaks
Up to 30 days post-surgery
Proportion of subjects with subclinical / radiological leaks
Up to 30 days post-surgery
Proportion of subjects with at least one Serious Adverse Event
Up to 30 days post-surgery
Proportion of subjects that had a reoperation
Up to 30 days post-surgery
Hospital length of stay
Up to 30 days post-surgery
Study Arms (1)
Seal G / Seal-G MIST
EXPERIMENTALSeal-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.
Interventions
Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis
Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Medical Solutions Ltd.lead
- ClinSearchcollaborator
- Advanced Medical Solutions Israel (Sealantis) Ltd.collaborator
Study Sites (2)
Sheba Medical Center (Tel Hashomer)
Ramat Gan, Israel
Shamir (Assaf Harofeh) Medical Center
Rishon LeZiyyon, Israel
Related Publications (1)
Kamar M, Kanani F, Spinelli A, Jayne D, Segev L, Tutton M, Montroni I, Tulchinsky H, Shimonov M, Lavy R, Zmora O. Efficacy and safety of novel alginate-based sealants (SEAL-G and SEAL-G MIST) in reducing anastomotic leakage following colorectal anastomosis: a prospective multicenter study. Ann Coloproctol. 2025 Oct;41(5):424-433. doi: 10.3393/ac.2025.00297.0042. Epub 2025 Oct 23.
PMID: 41125251DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Moshe Kamar, MD
Advanced Medical Solutions Israel (Sealantis) Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 31, 2020
Study Start
February 1, 2021
Primary Completion
July 25, 2023
Study Completion
October 30, 2023
Last Updated
December 11, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share