Esophageal DiseasesNCT06835374
Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
A study testing Per oral endoscopy myotomy (Per oral endoscopy myotomy) and Endoscopy procedure in people with Esophageal Diseases, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- Per oral endoscopy myotomy (Per oral endoscopy myotomy) and Endoscopy procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 11 May 2024to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18y,
- confirmed diagnosis of Achalasia,
- No contraindication to POEM,
- erosive esophagitis on endoscopy
Who cannot join
- Non-esophageal esophageal motility disorders,
- Treatment other than POEM,
- current PPI use before assessment for GERD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, 500082
Mohan Ramchandani, MBBS, 04023378888 ext. 802, ramchandanimohan@gmail.com
Chinmay Hegde, MBBS, MD, 04023378888 ext. 102, chinhegde123@gmail.com
About this study
Official title: Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
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
- Demographic characteristics: Age, gender, type of achalasia
- Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure
- Comorbidities
- Medications
- Eckardt score: before procedure and 3-months after Procedure
- POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay
- Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
Read the detailed description
POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.
- Conditions
- Esophageal Diseases
- Being tested
- Per oral endoscopy myotomy (Per oral endoscopy myotomy), Endoscopy procedure
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per oral endoscopy myotomy (Per oral endoscopy myotomy)Procedure or surgery
POEM is the procedure to reduce the symptoms of dysphagia, regurgitation.
Endoscopy procedureProcedure or surgery
Endoscopy procedure is required to rule out type of reflux disease
| Study group | Role | What they receive |
|---|---|---|
| Assesment of reflux esophagitis in cases with esophageal motility | Active comparator | Reflux esophagitis can be found in Endoscopy report. Receives: Procedure: Per oral endoscopy myotomy (Per oral endoscopy myotomy) |
| Assesment of reflux esophagitis in cases without esophageal motility | Placebo comparator | Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients Receives: Procedure: Endoscopy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure
Measured: 3 months
Assessment of the , esophageal acid exposure
esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start11 May 2024
- Primary completion28 May 2026 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Zaheer Nabi Dr Mohammed, MBBS MD, Principal investigator, AIG HospitalsChinmay Dr Hegde, MBBS MD, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835374
- Sponsor's protocol ID
- REP
- Status last verified
- May 2026
- First submitted
- 8 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
- ClinicalTrials.gov ID
- NCT06835374
- Acronym / sponsor ID
- REP
- Conditions
- Esophageal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 11 May 2024 (actual)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Demographic characteristics: Age, gender, type of achalasia
- Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure
- Comorbidities
- Medications
- Eckardt score: before procedure and 3-months after Procedure
- POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay
- Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
Detailed description
POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assesment of reflux esophagitis in cases with esophageal motility | Active comparator | Procedure: Per oral endoscopy myotomy (Per oral endoscopy myotomy)Reflux esophagitis can be found in Endoscopy report. |
| Assesment of reflux esophagitis in cases without esophageal motility | Placebo comparator | Procedure: Endoscopy procedureReflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18y,
- confirmed diagnosis of Achalasia,
- No contraindication to POEM,
- erosive esophagitis on endoscopy
Key exclusion criteria (3 listed)
- Non-esophageal esophageal motility disorders,
- Treatment other than POEM,
- current PPI use before assessment for GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per oral endoscopy myotomy (Per oral endoscopy myotomy)POEM is the procedure to reduce the symptoms of dysphagia, regurgitation. | Procedure or surgery | Assesment of reflux esophagitis in cases with esophageal motility |
| Endoscopy procedureEndoscopy procedure is required to rule out type of reflux disease | Procedure or surgery | Assesment of reflux esophagitis in cases without esophageal motility |
Primary outcome
comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
Time frame: 3 months
Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure
Assessment of the , esophageal acid exposure
Time frame: 6 months
esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Diseases
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zaheer Nabi Dr Mohammed, MBBS MD principal investigator
AIG Hospitals
Chinmay Dr Hegde, MBBS MD principal investigator
AIG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per oral endoscopy myotomy (Per oral endoscopy myotomy) and Endoscopy procedure in people with Esophageal Diseases, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Goud Mr Maragoni, M.Pharm, MBA (04023378888 ext. 531, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.