Clinical trial · Interventional
Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
Seal-G MIST System Safety Study [SEALAR Study]
NCT03448874CI-TRIAL-00046289SEALARwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The company will design a new study
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing colorectal anastomosis, in subjects undergoing colorectal 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diverticulitis Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seal-G MIST System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Seal-G MIST System
- description
- Seal-G MIST System is a surgical sealant that will be applied adjunctively to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
- interventionNames
- Device: Seal-G MIST System
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Patients in the control arm will receive the standard of care \[SOC\] for colorectal resection surgery with primary anastomosis (no additional intervention)
Primary outcomes (1)
- measure
- Incidence of overall subject pre-specified* procedure related Adverse Events
- timeFrame
- up to 15 weeks (±2 weeks) post-surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject \>18 years 2. Subject is scheduled for elective open or laparoscopic colorectal resection (including left colectomy, sigmoidectomy, anterior resection, subtotal colectomy) surgery (including robotic) involving the creation of circular stapler anastomosis 3. Subject signs and dates a written Informed Consent Form, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them 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 American Society of Anesthesiologists (ASA) status higher than 3 6. Albumin level \< 3 gr/dl 7. Hemoglobin level \< 8 g/dl on day of surgery 8. Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis 9. Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids) 10. 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 diabetes mellitus with episodes of hospitalization due to hypo or hyperglycemia within 6 months of surgery) 11. Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes) 12. Subject with known sensitivity to Indigo carmine dye (E132) 13. Subject who according to the investigator clinical judgement is not suitable for participation in the study 14. Subject with a life expectancy of less than 1 year 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. Subject participating in any other study involving an investigational (unapproved) drug or device 18. Woman who is known to be pregnant or breast-feeding or woman who is planning pregnancy or breast-feeding in the 5 next months 19. Vulnerable subjects (e.g. mentally handicapped, prisoners, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.