Clinical trial · Interventional
TECR & ECM Placement for Esophageal High Grade Dysplasia
A Prospective Feasibility Study to Evaluate the Safety and Efficacy of Transoral Endoscopic Circumferential Esophageal Resection With Extracellular Matrix (ECM) Placement to Treat Barrett's Esophagus With High-grade Dysplasia (HGD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Serious Adverse Event of Patient who completed study and follow-up.
Summary
Brief summary (as posted)
This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.
Conditions
Conditions (3)
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 Esophagus | — | UNRESOLVED | — |
| Esophagus | — | UNRESOLVED | — |
| High Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TECR & ECM
- description
- Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)
- interventionNames
- Device: Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))
Primary outcomes (4)
- measure
- Efficacy: Stricture Formation
- timeFrame
- 12 months following procedure
- description
- To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
1. Be at least 18 years of age and no more than 80 years of age.
2. Have an established diagnosis of HGD
a. Specific diagnosis and grading will be determined by pathology review of biopsy tissue collected during baseline EGD as part of a patient's standard of care.
3. Have no evidence of lymphovascular invasion.
4. Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
5. Diameter of affected tissue must warrant circumferential excision a. Subjects must have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are normal (contain no HGD) they must be located on separate levels in two different quadrants.
5\. Must be an appropriate or reasonable surgical candidate. 6. Have demonstrated an understanding and signed an approved informed consent form for participation in this study.
Exclusion Criteria:
1. Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal adenocarcinoma).
a. Those requiring endoscopic submucosal dissection (ESD) are not eligible for this study
2. Have presence of lymphovascular invasion.
3. Require resection length longer than 10 cm.
4. Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
5. Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).
6. Are pregnant or planning to become pregnant.
7. Have coagulation disorders.
8. Have a known hypersensitivity to porcine-based materials.
9. Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
10. Has a clinically significant psychological illness that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
11. Are unable or unwilling to provide informed consent and/or fulfill the protocol follow-up requirements.
\-References
Publications (16)
- BACKGROUNDRice TW, Zuccaro G Jr, Adelstein DJ, Rybicki LA, Blackstone EH, Goldblum JR. Esophageal carcinoma: depth of tumor invasion is predictive of regional lymph node status. Ann Thorac Surg. 1998 Mar;65(3):787-92. doi: 10.1016/s0003-4975(97)01387-8. PMID 9527214
- BACKGROUNDWitteman BP, Foxwell TJ, Monsheimer S, Gelrud A, Eid GM, Nieponice A, O'Rourke RW, Hoppo T, Bouvy ND, Badylak SF, Jobe BA. Transoral endoscopic inner layer esophagectomy: management of high-grade dysplasia and superficial cancer with organ preservation. J Gastrointest Surg. 2009 Dec;13(12):2104-12. doi: 10.1007/s11605-009-1053-x. Epub 2009 Oct 14. PMID 19826883
- BACKGROUNDBadylak SF, Vorp DA, Spievack AR, Simmons-Byrd A, Hanke J, Freytes DO, Thapa A, Gilbert TW, Nieponice A. Esophageal reconstruction with ECM and muscle tissue in a dog model. J Surg Res. 2005 Sep;128(1):87-97. doi: 10.1016/j.jss.2005.03.002. PMID 15922361
- BACKGROUNDNieponice A, Gilbert TW, Badylak SF. Reinforcement of esophageal anastomoses with an extracellular matrix scaffold in a canine model. Ann Thorac Surg. 2006 Dec;82(6):2050-8. doi: 10.1016/j.athoracsur.2006.06.036. PMID 17126109
- BACKGROUNDNieponice A, McGrath K, Qureshi I, Beckman EJ, Luketich JD, Gilbert TW, Badylak SF. An extracellular matrix scaffold for esophageal stricture prevention after circumferential EMR. Gastrointest Endosc. 2009 Feb;69(2):289-96. doi: 10.1016/j.gie.2008.04.022. Epub 2008 Jul 26. PMID 18657808
- BACKGROUNDBadylak SF, Hoppo T, Nieponice A, Gilbert TW, Davison JM, Jobe BA. Esophageal preservation in five male patients after endoscopic inner-layer circumferential resection in the setting of superficial cancer: a regenerative medicine approach with a biologic scaffold. Tissue Eng Part A. 2011 Jun;17(11-12):1643-50. doi: 10.1089/ten.TEA.2010.0739. Epub 2011 Mar 28. PMID 21306292
- Hoppo T, Badylak SF, Jobe BA. A novel esophageal-preserving approach to treat high-grade dysplasia and superficial adenocarcinoma in the presence of chronic gastroesophageal reflux disease. World J Surg. 2012 Oct;36(10):2390-3. doi: 10.1007/s00268-012-1698-6.