Clinical trial · Interventional
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
NCT04532515CI-TRIAL-00072137completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seal-G MIST System | Device | — | UNRESOLVED |
| Seal-G Surgical Sealant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Seal G / Seal-G MIST
- description
- 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.
- interventionNames
- Device: Seal-G Surgical Sealant
- Device: Seal-G MIST System
Primary outcomes (1)
- measure
- Proportion of surgeries with full sealant coverage - successful application
- timeFrame
- At time of surgery
- description
- 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 outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 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: 1. Anastomosis is expected to be ≤ 10cm from anal verge 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.) 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: 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
References
Publications (1)
- DERIVEDKamar 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 41125251