Clinical trial · Observational
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia. The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria. A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Obstruction | — | UNRESOLVED | — |
| Gastrointestinal Neoplasia | — | UNRESOLVED | — |
| Gastroparesis | — | UNRESOLVED | — |
| Hirschsprung's Disease | — | UNRESOLVED | — |
| Spastic Esophageal Disorders | — | UNRESOLVED | — |
| Zenker's Diverticulum | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Technical and clinical success in performing submucosal endoscopy
- timeFrame
- baseline to one year
- description
- Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.
- measure
- Adverse Events
- timeFrame
- baseline to one year
- description
- as defined by published ASGE criteria
Secondary outcomes (2)
- measure
- Procedure time
- timeFrame
- During procedure
- description
- Procedure time
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who will undergo submucosal endoscopy 2. Age \>18 years Exclusion Criteria: 1. Age \<18 years 2. Pregnancy 3. Coagulopathy (platelets less than 50, INR more than 1.8)
References
Publications (0)
Data not yet available