Colorectal CancerSEALARNCT03448874
Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
A study testing Seal-G MIST System in people with Colorectal Cancer and Diverticulitis Colon, run by Sealantis Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticulitis Colon
- What is being tested?
- Seal-G MIST System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.)
About this study
Official title: Seal-G MIST System Safety Study [SEALAR Study]
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)
- Conditions
- Colorectal Cancer, Diverticulitis Colon
- Being tested
- Seal-G MIST System
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seal-G MIST SystemDevice
Also called Seal-G MIST
Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 15 weeks (±2 weeks) post-surgery
Secondary outcomes (8)
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.
Measured: up to 15 weeks (±2 weeks) post-surgery
Incidence of subclinical/ radiological leaks
As assessed from Adverse event/Serious Adverse Event reporting form
Measured: up to 15 weeks (±2 weeks) post-surgery
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)
Measured: up to 15 weeks (±2 weeks) post-surgery
Incidence of collection/abscess without demonstrated leak
According to Adverse event reporting form
Measured: up to 15 weeks (±2 weeks) post-surgery
Incidence of reoperation
According to Adverse event/Serious Adverse Event reporting form
Measured: up to 30 days post-surgery
Incidence of postoperative mortality
Measured: up to 15 weeks (±2 weeks)
Hospital length of stay
Measured: From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days
Incidence of "deployment failure"
only for treatment arm
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: The company will design a new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, Randomized, single blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sealantis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Kamar, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448874
- Sponsor's protocol ID
- DLG-072-06
- Acronym
- SEALAR
- Status last verified
- Jul 2020
- First submitted
- 19 Feb 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seal-G MIST System Safety Study [SEALAR Study]
- ClinicalTrials.gov ID
- NCT03448874
- Acronym / sponsor ID
- SEALAR / DLG-072-06
- Conditions
- Colorectal Cancer, Diverticulitis Colon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company will design a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sealantis Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Controlled, Randomized, single blind study
| Arm | Type | Receives |
|---|---|---|
| Seal-G MIST System | Experimental | Device: Seal-G MIST SystemSeal-G MIST System is a surgical sealant that will be applied adjunctively to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seal-G MIST SystemAlso: Seal-G MISTSeal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques. | Device | Seal-G MIST System |
Primary outcome
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).
8 secondary outcomes
Incidence of clinical anastomotic leaks
Time frame: up to 15 weeks (±2 weeks) post-surgery
Incidence of subclinical/ radiological leaks
Time frame: up to 15 weeks (±2 weeks) post-surgery
Incidence of Serious Adverse Events (SAE) complications
Time frame: up to 15 weeks (±2 weeks) post-surgery
Incidence of collection/abscess without demonstrated leak
Time frame: up to 15 weeks (±2 weeks) post-surgery
Incidence of reoperation
Time frame: up to 30 days post-surgery
Incidence of postoperative mortality
Time frame: up to 15 weeks (±2 weeks)
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
Incidence of "deployment failure"
Time frame: during surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Kamar, MD study director
Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A study testing Seal-G MIST System in people with Colorectal Cancer and Diverticulitis Colon, run by Sealantis Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of overall subject pre-specified* procedure related Adverse Events (time frame: up to 15 weeks (±2 weeks) post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.