Esophageal DiseasesNCT06870630
Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
A study testing Per oral endoscopy myotomy in people with Esophageal Diseases, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. 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
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteIndia
- Study dates
- 29 Nov 2023to 30 Jul 2025
- 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
- Adult >18 years
- Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Who cannot join
- Patients with Type 1 \& 3 ACHALASIA CARDIA
- Patients with previous endoscopic or surgical treatment for achalasia
- Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio > 1.5, platelet count < 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
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 /Aig Hospitals
Hyderabad, Telangana, 500082
ZAHEER DR NABI, MBBS MDDNB, 04023378888, zaheernabi1978@gmail.com
About this study
- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Read the detailed description
. Primary objective -
- To study the incidence of true reflux on 24 hour pH analysis with manual study.
Secondary objective -
- To analyse treatment success which is defined as Eckdart score < 3 at follow up assessment ( 3rd month)
- To analyse the recovery of peristalsis after POEM using High resolution manometry
- To study total procedure time , intra operative adverse effects and duration of hospital stay.
- Severity of oesophagitis
- Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.
- Conditions
- Esophageal Diseases
- Being tested
- Per oral endoscopy myotomy
- 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 myotomyDevice
Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Per oral endoscopy myotomy for standard myotomy | Active comparator | Standard myotomy is muscle fibers cutting in esophagus more than 7 cms Receives: Device: Per oral endoscopy myotomy |
| Per oral endoscopy myotomy for esophago gastric junction myotomy | Sham comparator | Myotomy is muscle fibers cutting in esophagus less than 3 cms. Receives: Device: Per oral endoscopy myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of true reflux based on 24-hour pH impedence
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
Measured: 3 months
Integrated Relaxation Pressure (IRP) at High resolution manometry test
IRP in mm Hg measures pressure in the esophagus
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start29 Nov 2023
- Primary completion14 Jun 2025 (estimated)
- Study completion30 Jul 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 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
- Mohan Dr Ramchandani, MBBS MD, Study director, AIG HospitalsZaheer Dr Nabi, MBBS MD, Principal investigator, AIG HospitalsPradev Dr Inovolu, MBBS MD, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870630
- Sponsor's protocol ID
- POEMUSM
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
- ClinicalTrials.gov ID
- NCT06870630
- Acronym / sponsor ID
- POEMUSM
- Conditions
- Esophageal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 14 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 11 Mar 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.
- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Detailed description
. Primary objective -
- To study the incidence of true reflux on 24 hour pH analysis with manual study.
Secondary objective -
- To analyse treatment success which is defined as Eckdart score < 3 at follow up assessment ( 3rd month)
- To analyse the recovery of peristalsis after POEM using High resolution manometry
- To study total procedure time , intra operative adverse effects and duration of hospital stay.
- Severity of oesophagitis
- Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Per oral endoscopy myotomy for standard myotomy | Active comparator | Device: Per oral endoscopy myotomyStandard myotomy is muscle fibers cutting in esophagus more than 7 cms |
| Per oral endoscopy myotomy for esophago gastric junction myotomy | Sham comparator | Device: Per oral endoscopy myotomyMyotomy is muscle fibers cutting in esophagus less than 3 cms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult >18 years
- Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Key exclusion criteria (3 listed)
- Patients with Type 1 \& 3 ACHALASIA CARDIA
- Patients with previous endoscopic or surgical treatment for achalasia
- Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio > 1.5, platelet count < 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
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 myotomyPoem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss. | Device | Per oral endoscopy myotomy for esophago gastric junction myotomy, Per oral endoscopy myotomy for standard myotomy |
Primary outcome
Incidence of true reflux based on 24-hour pH impedence
Time frame: 3 months
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
Integrated Relaxation Pressure (IRP) at High resolution manometry test
Time frame: 3 months
IRP in mm Hg measures pressure in the esophagus
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 10 Jun 2025.
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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.
Mohan Dr Ramchandani, MBBS MD study director
AIG Hospitals
Zaheer Dr Nabi, MBBS MD principal investigator
AIG Hospitals
Pradev Dr Inovolu, 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 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 2 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 10 Jun 2025. 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 Dr Goud, M.Pharm, MBA (04023378888 ext. 204, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of true reflux based on 24-hour pH impedence (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 10 Jun 2025.