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Achalasia CardiaPhase 2NCT07875686

Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial

A Phase 2 study testing Full thickness myotomy and Progressive thickness myotomy in people with Achalasia Cardia and Achalasia, run by Cairo University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Peroral endoscopic esophageal myotomy (POEM) has been established as an effective therapy for Achalasia. It is still not known how deep the myotomy should be and if it should include the circular and longitudinal muscles or not. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Achalasia Cardia, Achalasia
What is being tested?
Full thickness myotomy and Progressive thickness myotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesEgypt
Study dates
1 Aug 2025to 30 Jan 2027
Phase
Phase 2
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Achalasia confirmed by manometry
  • Type 1 and type 2 Achalasia
  • Eckhart score >3
  • Fit to undergo anaesthesia

Who cannot join

  • Type 3 achalasia and other esophageal motility Disorders
  • Hiatus hernia
  • Coagulopathy

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hany Shehab contact

+201111111071

h.shehab@kasralainy.edu.eg

Ahmed 3lbadry contact

+20 10 66860084

Egypt2 sites, 2 recruiting

  • Cairo University

    Cairo

    Hany Shehab

    Recruiting

  • Theodore Bilharz Institute

    Cairo

    Khaled Ragab

    Recruiting

Other trials in Egypt

About this study

Peroral endoscopic esophageal myotomy (POEM) has been established as an effective therapy for Achalasia. It is still not known how deep the myotomy should be and if it should include the circular and longitudinal muscles or not. It is hypothesized that a complete full thickness myotomy could lead to higher rates of gastroesophageal reflux disease (GERD). In this study we compare performing a Full-thickness myotomy with a progressive myotomy (proximal half circular only, distal half full-thickness, and assessment the different outcomes including efficacy and the incidence of postprocedural GERD.

Being tested
Full thickness myotomy, Progressive thickness myotomy
Keywords
Achalasia, POEM, Peroral endoscopic esophageal myotomy
Medical subject headings
Esophageal Achalasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full thickness myotomyProcedure or surgery

    Full thickness myotomy

  • Progressive thickness myotomyProcedure or surgery

    Progressive thickness myotomy

Study groups in NCT07875686
Study groupRoleWhat they receive
FULL THICKNESS MYOTOMYActive comparatorProcedure will include a full thickness myotomy including both the circular and longitudinal muscle layers throughout the whole length of the myotomy
Receives: Procedure: Full thickness myotomy
Progressive myotomyActive comparatorProcedure will include a progressive thickness myotomy where the proximal half of the myotomy will be selective cutting only the circular muscles, while the distal half will include both circular and longitudinal muscles.
Receives: Procedure: Progressive thickness myotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of Esophagitis

    Any degree of esophagitis detected endoscopically

    Measured: 6 months after the POEM procedure

Secondary outcomes (4)

  1. Clinical improvement

    ECKHART score

    Measured: 6 months after the POEM procedure

  2. Ph manometry

    Demeester score

    Measured: 6 months after the POEM procedure

  3. Duration of myotomy

    Duration of myotomy

    Measured: During the procedure

  4. Adverse events

    Any adverse events

    Measured: up to 6 months after the POEM procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start1 Aug 2025
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07875686
Sponsor's protocol ID
POEM-FT
Status last verified
Oct 2025
First submitted
8 May 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Full thickness myotomy and Progressive thickness myotomy in people with Achalasia Cardia and Achalasia, run by Cairo University at 2 sites in Egypt.

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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hany Shehab (+201111111071, h.shehab@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Esophagitis (time frame: 6 months after the POEM procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07875686.

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 15 Oct 2026.

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