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Endoscopic Full Thickness Plication for esophageal abnormal acid exposure post Peroral endoscopic myotomy

A randomised study comparing Endoscopic Full Thickness Plication (GERD-X) vs. Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019819
Enrollment
30
Registered
2019-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K220- Achalasia of cardia

Interventions

Intervention1: GERD-X group: Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under anesthesia. Guidewire will be placed into the stomac

Sponsors

Endoscopy Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged 18-70 years and above 2. Aachalasia cardia patients minimum 3 months post POEM with abnormal 24hr pH metry, regardless of symptoms 3. Abnormal esophageal acid exposure defined as percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI for atleast 1 week 4. Patients agreeing to informed consent

Exclusion criteria

Exclusion criteria: 1. Failed POEM â?? elevated integrated relaxation pressure and lower esophageal sphincter pressure 2. Hiatus hernia hills 3 or more 3. Patients with significant renal or liver disease 4. Grade D esophagitis 5. Barrettâ??s esophagus 6. ASA physical status >II 7. Pregnancy

Design outcomes

Primary

MeasureTime frame
Improvement of abnormal acid exposure by 24 hr ph studyTimepoint: 1 month

Secondary

MeasureTime frame
Improvement in GERD-QTimepoint: 1 month and 3 months

Countries

India

Contacts

Public ContactDr Gaurav Patil

Baldota Institute of Digestive Sciences

gauravkpatil@gmail.com9650355454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026