Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]

NCT03448874 | Withdrawn

• 1 other identifier: DLG-072-06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing colorectal anastomosis, in subjects undergoing colorectal surgery.

Conditions

Colorectal Cancer; Diverticulitis Colon

Outcome Measures

Primary Outcomes (1)

• Incidence of overall subject pre-specified* procedure related Adverse Events

  Pre-specified procedure related Adverse Event: Wound infection; Bowel obstruction and Post-operative ileus; Anastomotic stricture; Anastomotic leak; Collection/Abscess; Urinary retention/Urinary Tract Infection; Renal failure; Hepatic failure; Peritoneal metastasis; Staple-line bleeding; Allergic reaction; Re-intervention (Including but not limited to re-operation; stoma).

  up to 15 weeks (±2 weeks) post-surgery

Secondary Outcomes (8)

• Incidence of clinical anastomotic leaks

  up to 15 weeks (±2 weeks) post-surgery

• Incidence of subclinical/ radiological leaks

  up to 15 weeks (±2 weeks) post-surgery

• Incidence of Serious Adverse Events (SAE) complications

  up to 15 weeks (±2 weeks) post-surgery

• Incidence of collection/abscess without demonstrated leak

  up to 15 weeks (±2 weeks) post-surgery

• Incidence of reoperation

  up to 30 days post-surgery

Study Arms (2)

Seal-G MIST System

EXPERIMENTAL

Seal-G MIST System is a surgical sealant that will be applied adjunctively to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.

Device: Seal-G MIST System

Standard of care

NO INTERVENTION

Patients in the control arm will receive the standard of care \[SOC\] for colorectal resection surgery with primary anastomosis (no additional intervention)

Interventions

Seal-G MIST System DEVICE

Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.

Also known as: Seal-G MIST

Seal-G MIST System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject \>18 years
• 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
• 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

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 American Society of Anesthesiologists (ASA) status higher than 3
• Albumin level \< 3 gr/dl
• Hemoglobin level \< 8 g/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 diabetes mellitus 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 (E132)
• Subject who according to the investigator clinical judgement is not suitable for participation in the study
• Subject with a life expectancy of less than 1 year
• Subject requires more than one anastomosis during the surgery

Sponsors & Collaborators

• Sealantis Ltd.: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticulitis, Colonic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticulitis; Diverticular Diseases; Gastroenteritis; Diverticulosis, Colonic

Study Officials

• Moshe Kamar, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is single blinded. The subject will be blinded to the treatment arm; however, by nature of the type of the proposed study, blinding of the investigator/ surgeon is not feasible. In order to minimize bias, subjects will be randomized during the surgery upon confirmation of the intra-operative exclusion criteria. This will ensure that the surgeon will not know prior to surgery and until completion of anastomosis creation, whether or not Seal-G MIST will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Controlled, Randomized, single blind study

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07