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A study to assess a new endoscopy guided procedure to ameliorate acid reflux

A prospective pilot study to assess safety and feasibility of anti reflux mucosectomy for gastroesophageal reflux disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009182
Enrollment
25
Registered
2017-07-31
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: null- Gastro esophageal reflux disease

Interventions

Intervention1: Anti reflux mucosectomy: Standard endoscopic mucosectomy techniques are followed to resect the mucosa of the fundus on the lesser curve Control Intervention1: Not applicable: Not applic

Sponsors

Endoscopy Research foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with gastroesophageal reflux disease

Exclusion criteria

Exclusion criteria: 1 >Patients who are below 18 years age 2 >Patients who are pregnant or breast feeding 3 >Patients who are unable to give consent 4 >Patients with hiatus hernia, patients not fit for general anaesthesia. 5 >Patients with NERD, Hypersensitive oesophagus 6 >Patients with oesophageal dysmotility

Design outcomes

Primary

MeasureTime frame
To alleviate GERD symptoms without any adverse effects to the patientTimepoint: week 4, 12

Secondary

MeasureTime frame
Technical success- This is defined as an adequate mucosectomy on the oesophageal and gastric side has been achieved Treatment success- Relief from the symptoms of GERD, stopping of PPI therapy with normalizing of 24 pH test. Technical failure- Failure to perform a adequate mucosectomy Procedural duration â?? Time taken for the mucosectomy Length of hospital stay for any complications 24 hour pH and OGD findings on week 8. Timepoint: week 4, 12

Countries

India

Contacts

Public ContactAmit Maydeo

Global Hospital, Mumbai

amitmaydeo@gmail.com022267670312

Outcome results

None listed

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