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Colon CancerNCT04532515

Seal-G / Seal-G MIST Study

A study testing Seal-G Surgical Sealant and Seal-G MIST System in people with Colon Cancer and Gastrointestinal Cancer, run by Advanced Medical Solutions Ltd. at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colon Cancer, Gastrointestinal Cancer
What is being tested?
Seal-G Surgical Sealant and Seal-G MIST System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesIsrael
Study dates
1 Feb 2021to 30 Oct 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
  • Subject is aged 18 years to 80 years
  • Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)

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 ASA status higher than 3
  • Albumin level < 3 gr/dl
Show all 25Show fewer
  • Total bilirubin >1.5 mg/dL
  • Hemoglobin level < 8mg/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 DM 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 (FD\&C 2/ E132)
  • Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
  • Subject requires more than one anastomosis during the surgery
  • Subject is scheduled for another surgery during the follow up period of this study
  • Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)
  • Intraoperative Exclusion Criteria:
  • Subjects who meet any of the following intra-operative exclusion criteria will be considered as screen failures and will not be eligible for the study:
  • Positive leak test requires anastomosis takedown and/or re-anastomosis.
  • Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
  • Subjects whom anastomosis is ≤10 cm from the anal verge
  • Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
  • Subject received two or more units of PC transfusion during surgery
  • Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Sheba Medical Center (Tel Hashomer)

    Ramat Gan

  • Shamir (Assaf Harofeh) Medical Center

    Rishon LeZiyyon

Other trials in Israel

About this study

Official title: Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection

A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery

Read the detailed description

Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate based sealant technology and intended purpose. The devices only differ in their method of application, The Seal-G device is designed for spread application by extra-corporal approach, and the Seal-G MIST device is designed for spray application by intra-corporal approach.

The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability.

Being tested
Seal-G Surgical Sealant, Seal-G MIST System
Medical subject headings
Colonic Neoplasms, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seal-G Surgical SealantDevice

    Also called Seal-G

    Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.

    Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis

  • Seal-G MIST SystemDevice

    Also called Seal-G MIST

    Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.

    Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis

Study groups in NCT04532515
Study groupRoleWhat they receive
Seal G / Seal-G MISTExperimentalSeal-G Surgical Sealant [Seal-G]- will be applied on colonic anastomosis created by extra-corporal approach. Seal-G MIST System [Seal-G MIST]- will be applied on colonic anastomosis created by intra-corporal approach.
Receives: Device: Seal-G Surgical Sealant; Device: Seal-G MIST System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of surgeries with full sealant coverage - successful application

    1- The surgeon applied the sealant over the full circumference of the anastomosis (successful application).

    0 - The surgeon did not fully cover the anastomosis circumference

    Measured: At time of surgery

Secondary outcomes (5)

  1. Proportion of subjects with clinical anastomotic leaks

    1 - The subject had a clinical anastomotic leak 0 - The subject did not have a clinical anastomotic leak

    Measured: Up to 30 days post-surgery

  2. Proportion of subjects with subclinical / radiological leaks

    1 - The subject had a Subclinical /radiological anastomotic leak 0 - The subject did not have a Subclinical /radiological anastomotic leak

    Measured: Up to 30 days post-surgery

  3. Proportion of subjects with at least one Serious Adverse Event

    1 - The subject had any Serious adverse event 0 - The subject did not have Serious adverse event

    Measured: Up to 30 days post-surgery

  4. Proportion of subjects that had a reoperation

    1 - The subject had any event of reoperation 0 - The subject did not have reoperation

    Measured: Up to 30 days post-surgery

  5. Hospital length of stay

    Measured by the time for "Ready to be discharged" (in days)

    Measured: Up to 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start1 Feb 2021
  3. Primary completion25 Jul 2023
  4. Study completion30 Oct 2023

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Seal-G Product Family variants will be used as the study device (Treatment) according to the following scheme: 1. Seal-G Surgical Sealant \[Seal-G\]- will be applied on colonic anastomosis created by extra-corporal approach. 2. Seal-G MIST System \[Seal-G MIST\]- will be applied on colonic anastomosis created by intra-corporal approach. Intended Use: Seal-G/Seal-G MIST are surgical sealants intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04532515
Sponsor's protocol ID
DLG-072-06
Status last verified
Dec 2023
First submitted
26 Aug 2020
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kamar M, Kanani F, Spinelli A, Jayne D, Segev L, Tutton M, Montroni I, Tulchinsky H, Shimonov M, Lavy R, Zmora O. Efficacy and safety of novel alginate-based sealants (SEAL-G and SEAL-G MIST) in reducing anastomotic leakage following colorectal anastomosis: a prospective multicenter study. Ann Coloproctol. 2025 Oct;41(5):424-433. doi: 10.3393/ac.2025.00297.0042. Epub 2025 Oct 23.

    PubMed 41125251

Questions about this trial

What is this clinical trial studying?

A study testing Seal-G Surgical Sealant and Seal-G MIST System in people with Colon Cancer and Gastrointestinal Cancer, run by Advanced Medical Solutions Ltd. at 2 sites in Israel.

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 25 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: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of surgeries with full sealant coverage - successful application (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04532515, which also lists 1 linked publication.

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 11 Dec 2023.

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