NCT06815341

Brief Summary

Classification for Stasis Esophagitis: Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
339

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

February 4, 2025

Last Update Submit

February 7, 2025

Conditions

Esophagus Disorder

Outcome Measures

Primary Outcomes (1)

  • The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.

    sub mucosal fibres determination in different muscles of esophagus

    100 minutes

Secondary Outcomes (1)

  • : To improve the technical outcomes of per oral endoscopy myotomy

    100 minutes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

339 subjects

You may qualify if:

  • Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
  • Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.

You may not qualify if:

  • Patients who underwent treatment other than achalasia
  • Lost to follow up patients.
  • Incomplete clinical record patients
  • Patients not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500079, India

COMPLETED

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Zaheer Nabi Dr Mohammed, MBBS MD

    AIG Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Goud Mr Maragoni, M.Pharm, MBA

CONTACT

04023378888rajeshgoud761@gmail.com

Zaheer Nabi Dr Mohammed, MBBS MD

CONTACT

04023378888zaheernabi1978@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 7, 2025

Study Start

August 14, 2021

Primary Completion

February 20, 2025

Study Completion

April 20, 2025

Last Updated

February 11, 2025

Record last verified: 2024-02

Locations

IN(2)