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NCT06835374
Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
NA trial testing Per oral endoscopy myotomy (Per oral endoscopy myotomy) in Esophageal Diseases in 200 participants. Currently enrolling.
28 February 2025
Quick facts
| Lead sponsor | Asian Institute of Gastroenterology, India |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 11 May 2024 |
| Primary completion | 28 February 2025 |
| Estimated completion | 10 May 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Per oral endoscopy myotomy (Per oral endoscopy myotomy)
- Endoscopy procedure
Conditions studied
- Esophageal Diseases — all drugs for Esophageal Diseases →
Sponsor
Asian Institute of Gastroenterology, India
Who can join
Adults 18 to 75, any sex, with Esophageal Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders. Data collection 1. Demographic characteristics: Age, gender, type of achalasia 2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure 3. Comorbidities 4. Medications 5. Eckardt score: before procedure and 3-months after Procedure 6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay 7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06835374
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Other Asian Institute of Gastroenterology, India trials
Trials by the same sponsor.
- NCT07486518 — A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy An · not yet recruiting
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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 NCT06835374 (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 Asian Institute of Gastroenterology, India
- Last refreshed: 19 February 2025
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