Clinical trial · Interventional
Endoscopic Mucosal Resection and Cellular Matrix
A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
NCT03240679CI-TRIAL-00063695terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty obtaining investigational product and study support.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Adenocarcinoma | Barrett Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Barretts Esophagus With High Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acell MatriStem® Surgical Matrix | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic submucosal resection with Extracelluar Matrix
- description
- Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
- interventionNames
- Device: Acell MatriStem® Surgical Matrix
- type
- NO_INTERVENTION
- label
- Endoscopic submucosal resection standard of care
- description
- Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
Primary outcomes (1)
- measure
- Completeness of EMR Site Healing at Follow up Endoscopy
- timeFrame
- approximately 3-4 months post EMR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.