AchalasiaPhase 3NCT06189859
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
A Phase 3 study testing endoscopic submucosal dissection using SPRAY COAG mode and endoscopic submucosal dissection using Precisect mode in people with Achalasia and Achalasia Cardia, run by Cairo University at 1 site in Egypt.
Trial summary
Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Achalasia Cardia
- What is being tested?
- endoscopic submucosal dissection using SPRAY COAG mode and endoscopic submucosal dissection using Precisect mode
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2024to Aug 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing POEM procedure for any esophageal motility disorder
- Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy
Who cannot join
- Esophageal varices
- Esophageal neoplasms
- Non-correctable coagulopathy
- Failure to provide an informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11562
Hany M Shehab, MD, 01111111071, H.shehab@kasralainy.edu.eg
Hany M Shehab, FRCP
About this study
Official title: Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.
- Conditions
- Achalasia, Achalasia Cardia
- Being tested
- endoscopic submucosal dissection using SPRAY COAG mode, endoscopic submucosal dissection using Precisect mode
- Keywords
- achalasia, POEM, ELECTROSURGERY, SPRAY COAGULATION, PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY
- Medical subject headings
- Esophageal Achalasia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal dissection using SPRAY COAG modeProcedure or surgery
Also called POEM
After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Spray coag mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection
endoscopic submucosal dissection using Precisect modeProcedure or surgery
After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Precisect mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection
| Study group | Role | What they receive |
|---|---|---|
| Spray coag mode | Active comparator | After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5) Receives: Procedure: endoscopic submucosal dissection using SPRAY COAG mode |
| Precisect mode | Active comparator | After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5) Receives: Procedure: endoscopic submucosal dissection using Precisect mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of endoscopic submucosal dissection
Speed of dissection (cm/minute)
Measured: during the procedure
Secondary outcomes (5)
Intraprocedural Bleeding
Bleeding necessitating change in electrosurgical mode
Measured: during the procedure
Significant Intraprocedural bleeding
Bleeding necessitating change of instrument to coagulating forceps
Measured: during the procedure
Other Adverse events
Including mucosal injury, postoperative pain, postoperative bleeding and other complications
Measured: during the procedure
Total procedure duration
Total procedure duration
Measured: during the procedure
Endoscopic submucosal tunneling duration
Endoscopic submucosal tunneling duration
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start16 Mar 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
- Investigators
- hany shehab, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189859
- Sponsor's protocol ID
- ESRCT
- Status last verified
- May 2025
- First submitted
- 19 Dec 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06189859
- Acronym / sponsor ID
- ESRCT
- Conditions
- Achalasia, Achalasia Cardia
- Keywords
- achalasia, POEM, ELECTROSURGERY, SPRAY COAGULATION, PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spray coag mode | Active comparator | Procedure: endoscopic submucosal dissection using SPRAY COAG modeAfter initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5) |
| Precisect mode | Active comparator | Procedure: endoscopic submucosal dissection using Precisect modeAfter initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing POEM procedure for any esophageal motility disorder
- Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy
Key exclusion criteria (4 listed)
- Esophageal varices
- Esophageal neoplasms
- Non-correctable coagulopathy
- Failure to provide an informed consent
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 |
|---|---|---|
| endoscopic submucosal dissection using SPRAY COAG modeAlso: POEMAfter initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Spray coag mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection | Procedure or surgery | Spray coag mode |
| endoscopic submucosal dissection using Precisect modeAfter initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Precisect mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection | Procedure or surgery | Precisect mode |
Primary outcome
Speed of endoscopic submucosal dissection
Time frame: during the procedure
Speed of dissection (cm/minute)
5 secondary outcomes
Intraprocedural Bleeding
Time frame: during the procedure
Significant Intraprocedural bleeding
Time frame: during the procedure
Other Adverse events
Time frame: during the procedure
Total procedure duration
Time frame: during the procedure
Endoscopic submucosal tunneling duration
Time frame: during the procedure
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 13 May 2025.
- Individual participant dataSharing planned: No
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Achalasia
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.
hany shehab principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endoscopic submucosal dissection using SPRAY COAG mode and endoscopic submucosal dissection using Precisect mode in people with Achalasia and Achalasia Cardia, run by Cairo University at 1 site 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 2 inclusion and 4 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 13 May 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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, MD, FRCP (+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?
Speed of endoscopic submucosal dissection (time frame: during the procedure). 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 13 May 2025.