Last reviewed · How we verify
NCT03626350
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
trial in Gastrointestinal Neoplasia in 250 participants. Participants enrolled and being followed up; not accepting new ones.
12 June 2025
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 12 June 2018 |
| Primary completion | 12 June 2025 |
| Estimated completion | 12 June 2025 |
| Sites | 1 location across United States |
Conditions studied
- Gastrointestinal Neoplasia — all drugs for Gastrointestinal Neoplasia →
- Hirschsprung's Disease — all drugs for Hirschsprung's Disease →
- Esophageal Obstruction — all drugs for Esophageal Obstruction →
- Gastroparesis — all drugs for Gastroparesis →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 89, any sex, with Gastrointestinal Neoplasia or Hirschsprung's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03626350 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 21 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03626350.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing