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

Primary Purpose

Colorectal Cancer, Diverticulitis Colon

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Seal-G MIST System

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Subject is scheduled for another surgery during the follow up period of this study
Subject participating in any other study involving an investigational (unapproved) drug or device
Woman who is known to be pregnant or breast-feeding or woman who is planning pregnancy or breast-feeding in the 5 next months
Vulnerable subjects (e.g. mentally handicapped, prisoners, etc.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Seal-G MIST System

Standard of care

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Incidence of subclinical/ radiological leaks

As assessed from Adverse event/Serious Adverse Event reporting form

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)

Incidence of collection/abscess without demonstrated leak

According to Adverse event reporting form

Incidence of reoperation

According to Adverse event/Serious Adverse Event reporting form

Incidence of postoperative mortality

Hospital length of stay

Incidence of "deployment failure"

only for treatment arm

Full Information

NCT ID

NCT03448874

First Posted

February 19, 2018

Last Updated

July 28, 2020

Sponsor

Sealantis Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03448874

Brief Title

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

Acronym

SEALAR

Official Title

Seal-G MIST System Safety Study [SEALAR Study]

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The company will design a new study

Study Start Date

April 2018 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sealantis Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Diverticulitis Colon

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Controlled, Randomized, single blind study

Masking

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.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Seal-G MIST System

Arm Type

Experimental

Arm 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.

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Seal-G MIST System

Other Intervention Name(s)

Seal-G MIST

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame