NCT06835374 Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
| NCT ID | NCT06835374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Esophageal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-11 |
| Primary Completion | 2026-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-05-11 with a primary completion date of 2026-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: 1. Age≥18y, 2. confirmed diagnosis of Achalasia, 3. No contraindication to POEM, 4. erosive esophagitis on endoscopy Exclusion Criteria: 1. Non-esophageal esophageal motility disorders, 2. Treatment other than POEM, 3. current PPI use before assessment for GERD
Contact & Investigator
Zaheer Nabi Dr Mohammed, MBBS MD
PRINCIPAL INVESTIGATOR
AIG Hospitals
Frequently Asked Questions
Who can join the NCT06835374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835374 currently recruiting?
Yes, NCT06835374 is actively recruiting participants. Contact the research team at rajeshgoud761@gmail.com for enrollment information.
Where is the NCT06835374 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT06835374 clinical trial?
NCT06835374 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Zaheer Nabi Dr Mohammed, MBBS MD at AIG Hospitals. The trial plans to enroll 200 participants.