Gastric CancerPhase 3NCT02519140
Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
A Phase 3 study testing Cook Medical EMR Gel in people with Gastric Cancer and Colon Cancer, run by Antonios Likourezos at 1 site in United States.
Trial summary
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Cancer, Colon Cancer
- What is being tested?
- Cook Medical EMR Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 30 Nov 2022
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pts undergoing sleeve gastrectomy
- Pts undergoing colectomy
Who cannot join
- Unable to give or understand consent
- All of the excised tissue will be needed for diagnostic purposes
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.
Read the detailed description
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.
- Conditions
- Gastric Cancer, Colon Cancer
- Being tested
- Cook Medical EMR Gel
- Keywords
- Gastric cancer, colon cancer, EMR, biopsy, bariatric surgery
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Medical EMR GelDrug
Also called Cook Medical EMR Gel will be injected submucosally
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
| Study group | Role | What they receive |
|---|---|---|
| Cook medical EMR Gel | Experimental | Prospective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease.
Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons.
Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel. Receives: Drug: Cook Medical EMR Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lift Efficacy
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
Measured: 1 hour
Secondary outcomes (1)
Dissection Adequacy
Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study start1 Aug 2014
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Danny Sherwinter, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519140
- Sponsor's protocol ID
- 2014-05-06
- Status last verified
- Oct 2023
- First submitted
- 17 Aug 2014
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8.
PubMed 23392984
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
- ClinicalTrials.gov ID
- NCT02519140
- Acronym / sponsor ID
- 2014-05-06
- Conditions
- Gastric Cancer, Colon Cancer
- Keywords
- Gastric cancer, colon cancer, EMR, biopsy, bariatric surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 10 Aug 2015 (estimated)
- 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.
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.
Detailed description
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cook medical EMR Gel | Experimental | Drug: Cook Medical EMR GelProspective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease. Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons. Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pts undergoing sleeve gastrectomy
- Pts undergoing colectomy
Key exclusion criteria (2 listed)
- Unable to give or understand consent
- All of the excised tissue will be needed for diagnostic purposes
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 |
|---|---|---|
| Cook Medical EMR GelAlso: Cook Medical EMR Gel will be injected submucosallyCook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens | Drug | Cook medical EMR Gel |
Primary outcome
Lift Efficacy
Time frame: 1 hour
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
1 secondary outcome
Dissection Adequacy
Time frame: 1 hour
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 4 Dec 2023.
- Background: PubMed 23392984Chandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8.
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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.
Danny Sherwinter, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cook Medical EMR Gel in people with Gastric Cancer and Colon Cancer, run by Antonios Likourezos at 1 site in United States.
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 2 inclusion and 2 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 4 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 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lift Efficacy (time frame: 1 hour). 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 NCT02519140, 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 4 Dec 2023.