Barretts Esophagus With High Grade DysplasiaNCT03240679
Endoscopic Mucosal Resection and Cellular Matrix
A study testing Acell MatriStem® Surgical Matrix in people with Barretts Esophagus With High Grade Dysplasia and Barrett Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With High Grade Dysplasia, Barrett Adenocarcinoma
- What is being tested?
- Acell MatriStem® Surgical Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 20 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to provide consent
- Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
- Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma
Who cannot join
- Pregnant women
- Prior esophageal EMR or ESD in the same region
- Anyone unable to provide informed consent
- Medical co-morbidities precluding EGD evaluation
- History of chemoradiotherapy to the neck/esophagus
- Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
- Being tested
- Acell MatriStem® Surgical Matrix
- Keywords
- Barrett's esophagus, Endoscopic Mucosal Resection
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acell MatriStem® Surgical MatrixDevice
Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal resection with Extracelluar Matrix | Active comparator | Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site. Receives: Device: Acell MatriStem® Surgical Matrix |
| Endoscopic submucosal resection standard of care | No intervention | Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of EMR Site Healing at Follow up Endoscopy
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
Measured: approximately 3-4 months post EMR
Secondary outcomes (1)
Presence of Stricture Formation at Follow up Endoscopy
Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).
Measured: approximately 3-4 months post EMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start22 Mar 2017
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Why it stopped: Difficulty obtaining investigational product and study support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barretts Esophagus With High Grade DysplasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study 10 in each group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240679
- Sponsor's protocol ID
- 16-006909
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2017
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
- ClinicalTrials.gov ID
- NCT03240679
- Acronym / sponsor ID
- 16-006909
- Keywords
- Barrett's esophagus, Endoscopic Mucosal Resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty obtaining investigational product and study support.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study 10 in each group
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal resection with Extracelluar Matrix | Active comparator | Device: Acell MatriStem® Surgical MatrixSubjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site. |
| Endoscopic submucosal resection standard of care | No intervention | –Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide consent
- Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
- Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma
Key exclusion criteria (6 listed)
- Pregnant women
- Prior esophageal EMR or ESD in the same region
- Anyone unable to provide informed consent
- Medical co-morbidities precluding EGD evaluation
- History of chemoradiotherapy to the neck/esophagus
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 |
|---|---|---|
| Acell MatriStem® Surgical MatrixExtracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time. | Device | Endoscopic submucosal resection with Extracelluar Matrix |
Primary outcome
Completeness of EMR Site Healing at Follow up Endoscopy
Time frame: approximately 3-4 months post EMR
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
1 secondary outcome
Presence of Stricture Formation at Follow up Endoscopy
Time frame: approximately 3-4 months post EMR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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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.
Kenneth K Wang principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acell MatriStem® Surgical Matrix in people with Barretts Esophagus With High Grade Dysplasia and Barrett Adenocarcinoma, run by Mayo Clinic 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Feb 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completeness of EMR Site Healing at Follow up Endoscopy (time frame: approximately 3-4 months post EMR). 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 6 Feb 2023.