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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448874
Recruitment Status : Withdrawn (The company will design a new study)
First Posted : February 28, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Sealantis Ltd.

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Diverticulitis Colon Device: Seal-G MIST System Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled, Randomized, single blind study
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Seal-G MIST System Safety Study [SEALAR Study]
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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
Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.
Other Name: Seal-G MIST

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)



Primary Outcome Measures :
  1. Incidence of overall subject pre-specified* procedure related Adverse Events [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]
    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).


Secondary Outcome Measures :
  1. Incidence of clinical anastomotic leaks [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]
    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.

  2. Incidence of subclinical/ radiological leaks [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]
    As assessed from Adverse event/Serious Adverse Event reporting form

  3. Incidence of Serious Adverse Events (SAE) complications [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]
    According to Serious Adverse Event (SAE) definition from Medical Device Directive (MEDDEV 2.7/3, Rev 3, May 2015)

  4. Incidence of collection/abscess without demonstrated leak [ Time Frame: up to 15 weeks (±2 weeks) post-surgery ]
    According to Adverse event reporting form

  5. Incidence of reoperation [ Time Frame: up to 30 days post-surgery ]
    According to Adverse event/Serious Adverse Event reporting form

  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" [ Time Frame: during surgery ]
    only for treatment arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448874


Sponsors and Collaborators
Sealantis Ltd.
Investigators
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Study Director: Moshe Kamar, MD Chief Medical Officer
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Responsible Party: Sealantis Ltd.
ClinicalTrials.gov Identifier: NCT03448874    
Other Study ID Numbers: DLG-072-06
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticulitis, Colonic
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Diverticulosis, Colonic