Barrett Adenocarcinoma Clinical Trial
Official title:
A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
NCT number | NCT03240679 |
Other study ID # | 16-006909 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2017 |
Est. completion date | June 20, 2017 |
Verified date | January 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | June 20, 2017 |
Est. primary completion date | June 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - 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 Exclusion Criteria - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | approximately 3-4 months post EMR | |
Secondary | 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). | approximately 3-4 months post EMR |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01618643 -
Aceto-whitening in the Assessment of Gastrointestinal Neoplasia
|
N/A | |
Completed |
NCT05628441 -
Real-time Computer Aided Detection of Barrett's Neoplasia
|
||
Recruiting |
NCT05690958 -
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening
|
||
Recruiting |
NCT03427346 -
Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
|
N/A | |
Completed |
NCT01871636 -
ESD Versus EMR for Treatment of Early Barrett`s Adenocarcinoma
|
N/A | |
Not yet recruiting |
NCT05276791 -
EMR Versus ESD for Barrett's Neoplasia
|
N/A | |
Completed |
NCT06381583 -
A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma
|