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WithdrawnNCT03448874SEALARUpdated Jul 30, 2020

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

An interventional study of Seal-G MIST System in Colorectal Cancer and Diverticulitis Colon, sponsored by Sealantis Ltd.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Sealantis Ltd. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The company will design a new study
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Study procedures:

Pre-surgery:

  • Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Once potential eligibility to the study is determined based on the study's inclusion/exclusion criteria, study procedures will be explained to the candidate and participation will be offered.
  • Informed consent process.
  • Pre-surgery assessments will be according to the routine practice at the site and determined by the treating physician.

Intra-operative:

  • During the surgery, after confirmation of the intra-operative exclusion criteria, completion of anastomosis creation and only after leak test was performed , subjects will be allocated to one of the two treatment arms with a 1:1 ratio based on a randomization scheme (either to the Standard of care (SOC) or to Seal-G MIST arms).
  • Device (Seal-G MIST System) application (to Seal-G MIST treatment arm only).

Post-operative follow-up:

  • Subjects will be followed during post-operative period until discharge from the hospital for clinical and subclinical leaks according to the SOC.
  • In an event of suspected anastomotic leak, patient will be treated according to severity of leak and PI clinical judgement (conservative treatment, drainage, diversion, anastomosis take down).

  • Subjects will be followed up for leaks and related AE/SAEs at the day of the surgery and for a period of 15 weeks (±2 weeks) post-surgery, including the following activities:

    • Daily while hospitalized (in accordance with the site routine procedures)
    • At 1 month (±1 week) and 15 weeks (±2 weeks) post-surgery (Hospitalization for elective procedure (i.e. chemotherapy treatments) will not be considered as SAEs)
02

Conditions studied

  • Colorectal Cancer
  • Diverticulitis Colon
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Seal-G MIST System

    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

  • No intervention
    Standard of care

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

Interventions

  • DeviceSeal-G MIST System

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

    Also known as: Seal-G MIST

05

What researchers measure

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).

    Time frame: up to 15 weeks (±2 weeks) post-surgery

Secondary outcomes

  1. Incidence of clinical anastomotic leaks

    Anastomotic leak (AL) is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to local or general peritonitis, abscesses in the proximity of the anastomosis and/or fistula, fecal or purulent discharge from drains.

    Time frame: up to 15 weeks (±2 weeks) post-surgery

  2. Incidence of subclinical/ radiological leaks

    As assessed from Adverse event/Serious Adverse Event reporting form

    Time frame: up to 15 weeks (±2 weeks) post-surgery

  3. Incidence of Serious Adverse Events (SAE) complications

    According to Serious Adverse Event (SAE) definition from Medical Device Directive (MEDDEV 2.7/3, Rev 3, May 2015)

    Time frame: up to 15 weeks (±2 weeks) post-surgery

  4. Incidence of collection/abscess without demonstrated leak

    According to Adverse event reporting form

    Time frame: up to 15 weeks (±2 weeks) post-surgery

  5. Incidence of reoperation

    According to Adverse event/Serious Adverse Event reporting form

    Time frame: up to 30 days post-surgery

  6. Incidence of postoperative mortality

    Time frame: up to 15 weeks (±2 weeks)

  7. Hospital length of stay

    Time frame: From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days

  8. Incidence of "deployment failure"

    only for treatment arm

    Time frame: during surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448874
Lead sponsor
Sealantis Ltd.
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Apr 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Jul 2019 (estimated)
Last update
Jul 30, 2020

Study contacts

Moshe Kamar, MD
study director · Chief Medical Officer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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