Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2021-02-01
2023-10-30
Brief Summary
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Detailed Description
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The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability.
Conditions
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Study Design
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NA
SINGLE_GROUP
1. Seal-G Surgical Sealant \[Seal-G\]- will be applied on colonic anastomosis created by extra-corporal approach.
2. Seal-G MIST System \[Seal-G MIST\]- will be applied on colonic anastomosis created by intra-corporal approach.
Intended Use: Seal-G/Seal-G MIST are surgical sealants 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
SUPPORTIVE_CARE
NONE
Study Groups
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Seal G / Seal-G MIST
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 Surgical Sealant
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 System
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
Interventions
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Seal-G Surgical Sealant
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 System
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is aged 18 years to 80 years
3. Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)
Exclusion Criteria
2. Surgery involves stoma creation
3. Subject who underwent a prior pelvic radiation therapy
4. Subject with a BMI \> 40 or \<19
5. Subject with ASA status higher than 3
6. Albumin level \< 3 gr/dl
7. Total bilirubin \>1.5 mg/dL
8. Hemoglobin level \< 8mg/dl on day of surgery
9. Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
10. Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
11. 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)
12. Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
13. Subject with known sensitivity to Indigo carmine dye (FD\&C 2/ E132)
14. Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
15. Subject requires more than one anastomosis during the surgery
16. Subject is scheduled for another surgery during the follow up period of this study
17. Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)
1. Positive leak test requires anastomosis takedown and/or re-anastomosis.
2. Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
3. Subjects whom anastomosis is ≤10 cm from the anal verge
4. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
5. Subject received two or more units of PC transfusion during surgery
6. Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon
18 Years
80 Years
ALL
No
Sponsors
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ClinSearch
OTHER
Advanced Medical Solutions Israel (Sealantis) Ltd.
UNKNOWN
Advanced Medical Solutions Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Moshe Kamar, MD
Role: STUDY_DIRECTOR
Advanced Medical Solutions Israel (Sealantis) Ltd.
Locations
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Sheba Medical Center (Tel Hashomer)
Ramat Gan, , Israel
Shamir (Assaf Harofeh) Medical Center
Rishon LeZiyyon, , Israel
Countries
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References
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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 23. doi: 10.3393/ac.2025.00297.0042. Online ahead of print.
Other Identifiers
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DLG-072-06
Identifier Type: -
Identifier Source: org_study_id