Vessel Puncture Site ReactionPOEMNCT07575295
A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy
An observational study of Vessel Puncture Site Reaction, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Peroral Endoscopic Myotomy (POEM) has become an established, minimally invasive therapy for achalasia and esophageal motility disorders. Submucosal tunnelling is a critical phase of POEM and requires meticulous haemostasis to avoid bleeding, loss of orientation, reduced visibility, and prolonged procedural time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vessel Puncture Site Reaction
- What is being tested?
- Under Water Preventive Coagulation
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2026to 30 Dec 2027
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 (60 in each arm)
Who may be able to join
- Age ≥ 18 years
- Diagnosis of achalasia or esophageal motility disorder planned for POEM
- Ability to provide informed consent
Who cannot join
- Anticoagulant or antithrombotic therapy not safely stoppable
- Known coagulopathy or platelet disorder
- Esophageal/gastric varices
- Previous POEM or Heller's myotomy
- Prior treatment for same condition
- Inability or refusal to consent
- Visualized vessels smaller than the HK inner diameter (1.2 mm)
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
Rajesh Goud Mr Maragoni, M.Pharm MBA, 04023378888 ext. 301, rajeshgoud761@gmail.com
About this study
Peroral Endoscopic Myotomy (POEM) has become an established, minimally invasive therapy for achalasia and esophageal motility disorders. Submucosal tunnelling is a critical phase of POEM and requires meticulous haemostasis to avoid bleeding, loss of orientation, reduced visibility, and prolonged procedural time.
The current standard method of vessel coagulation during POEM involves conventional coagulation under CO₂ insufflation using the hybrid knife (HK). However, this approach can require additional hemostatic devices-most commonly coagulation forceps-particularly when dealing with large-calibre vessels or resistant bleeding.
Read more
A novel technique-underwater preventive coagulation-leverages water as a conductive medium. Preliminary evidence suggests that:
- electrosurgical current in water is focalized at the interface of the vessel,
- allowing a soft sealing of the vessel wall,
- reducing the risk of vessel rupture or unintended deep thermal injury,
- and potentially eliminating the need to convert to coagulation forceps. Pilot data from our center demonstrate that underwater prophylactic sealing of large vessels during POEM is feasible, safe, and associated with markedly reduced need for rescue coagulation forceps. The technique is already used in practice but lacks systematic evidence from prospective randomized trials.
This study is designed to provide high-quality evidence on whether underwater vessel coagulation improves haemostatic efficiency, reduces intra-procedural bleeding, and minimizes device changes during POEM.
All POEM procedures will be performed under general anesthesia in the supine position using Fujifilm high-definition gastroscopes with a 2.8 mm channel and transparent distal cap.
Steps (Both Arms)
- Identify the esophagogastric junction (EGJ).
- Inject saline + methylene blue submucosally.
- Create a 2 cm mucosal incision at 5-6 o'clock position, 10 cm above EGJ.
- Enter the submucosal space.
- Perform submucosal tunnelling down to EGJ and 2-3 cm into cardia.
- Perform vessel haemostasis according to group allocation:
- Underwater coagulation (intervention)
- CO₂-based conventional coagulation (control)
- Perform circular myotomy (with occasional full-thickness myotomy when indicated).
- Close the mucosal entry using hemostatic clips.
- Record procedure time, instrument exchanges, bleeding events, and forceps usage.
Equipment
- Hybrid Knife (Erbe Elektromedizin GmbH)
- VIO 3 generator + ERBEJet 2 water-jet system
- Methylene-blue tinted saline
- Electrosurgical settings: ENDO CUT Q 2-3-3 for mucosal incision and myotomy
Read the detailed description
Primary Objective
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
- Underwater preventive vessel coagulation, and 2. Conventional vessel coagulation under CO₂ insufflation. Secondary Objectives
- To compare composite forceps use (rescue + prophylactic) between groups.
- To evaluate the frequency of prophylactic-only forceps use.
- To compare total number of forceps applications per procedure.
- To determine differences in intra-procedural bleeding episodes.
- To compare procedural efficiency (procedure time, number of instrument exchanges).
- To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC).
- To compare delayed bleeding rates within 30 days.
- To evaluate overall complication rates (intra- and post-procedural).
- To assess patient-reported outcomes (pain, tolerability). A prospective, randomized, open-label, parallel-group, controlled clinical trial.
Study Arms Intervention Arm: Underwater Coagulation
- Vessel coagulation performed entirely underwater using the Hybrid Knife.
- SWIFT COAG: E3 (89 W) for POEM.
- Physiological saline instilled to completely displace air around the target vessel.
Control Arm: Conventional Coagulation (CO₂ Setting)
- Standard vessel isolation and coagulation under CO₂ insufflation.
- SWIFT COAG: E3 (89 W) for POEM.
- Conditions
- Vessel Puncture Site Reaction
- Being tested
- Under Water Preventive Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Under Water Preventive CoagulationOther
Leverages water as a conductive medium. Preliminary evidence suggests that:
- electrosurgical current in water is focalized at the interface of the vessel,
- allowing a soft sealing of the vessel wall,
- reducing the risk of vessel rupture or unintended deep thermal injury,
- and potentially eliminating the need to convert to coagulation forceps.
| Study group | Role | What they receive |
|---|---|---|
| Under Water Coagulation | Intervention Arm: Underwater Coagulation
* Vessel coagulation performed entirely underwater using the Hybrid Knife.
* SWIFT COAG: E3 (89 W) for POEM.
* Physiological saline instilled to completely displace air around the target vessel. Receives: Other: Under Water Preventive Coagulation | |
| Conventional Coagulation | Control Arm: Conventional Coagulation (CO₂ Setting) * Standard vessel isolation and coagulation under CO₂ insufflation. * SWIFT COAG: E3 (89 W) for POEM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
- Underwater preventive vessel coagulation, and
- Conventional vessel coagulation under CO₂ insufflation.
Measured: 60 minutes
Secondary outcomes (9)
To compare composite forceps use (rescue + prophylactic) between groups.
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 60 minutes
To evaluate the frequency of prophylactic-only forceps use.
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 60 minutes
To compare total number of forceps applications per procedure.
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 60 minutes
To determine differences in intra-procedural bleeding episodes
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 60 minutes
To compare procedural efficiency (procedure time, number of instrument exchanges
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 60 minutes
To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC)
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 24 hours
To compare delayed bleeding rates
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 30 days
To evaluate overall complication rates (intra- and post-procedural)
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 24 hours
To assess patient-reported outcomes (pain, tolerability).
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Feb 2026
- Primary completion10 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vessel Puncture Site ReactionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 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, MD DM, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575295
- Sponsor's protocol ID
- POEM UWC 2026
- Acronym
- POEM
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy
- ClinicalTrials.gov ID
- NCT07575295
- Acronym / sponsor ID
- POEM / POEM UWC 2026
- Conditions
- Vessel Puncture Site Reaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 May 2026 (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 Myotomy (POEM) has become an established, minimally invasive therapy for achalasia and esophageal motility disorders. Submucosal tunnelling is a critical phase of POEM and requires meticulous haemostasis to avoid bleeding, loss of orientation, reduced visibility, and prolonged procedural time.
The current standard method of vessel coagulation during POEM involves conventional coagulation under CO₂ insufflation using the hybrid knife (HK). However, this approach can require additional hemostatic devices-most commonly coagulation forceps-particularly when dealing with large-calibre vessels or resistant bleeding.
A novel technique-underwater preventive coagulation-leverages water as a conductive medium. Preliminary evidence suggests that:
- electrosurgical current in water is focalized at the interface of the vessel,
- allowing a soft sealing of the vessel wall,
- reducing the risk of vessel rupture or unintended deep thermal injury,
- and potentially eliminating the need to convert to coagulation forceps. Pilot data from our center demonstrate that underwater prophylactic sealing of large vessels during POEM is feasible, safe, and associated with markedly reduced need for rescue coagulation forceps. The technique is already used in practice but lacks systematic evidence from prospective randomized trials.
This study is designed to provide high-quality evidence on whether underwater vessel coagulation improves haemostatic efficiency, reduces intra-procedural bleeding, and minimizes device changes during POEM.
All POEM procedures will be performed under general anesthesia in the supine position using Fujifilm high-definition gastroscopes with a 2.8 mm channel and transparent distal cap.
Steps (Both Arms)
- Identify the esophagogastric junction (EGJ).
- Inject saline + methylene blue submucosally.
- Create a 2 cm mucosal incision at 5-6 o'clock position, 10 cm above EGJ.
- Enter the submucosal space.
- Perform submucosal tunnelling down to EGJ and 2-3 cm into cardia.
- Perform vessel haemostasis according to group allocation:
- Underwater coagulation (intervention)
- CO₂-based conventional coagulation (control)
- Perform circular myotomy (with occasional full-thickness myotomy when indicated).
- Close the mucosal entry using hemostatic clips.
- Record procedure time, instrument exchanges, bleeding events, and forceps usage.
Equipment
- Hybrid Knife (Erbe Elektromedizin GmbH)
- VIO 3 generator + ERBEJet 2 water-jet system
- Methylene-blue tinted saline
- Electrosurgical settings: ENDO CUT Q 2-3-3 for mucosal incision and myotomy
Detailed description
Primary Objective
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
- Underwater preventive vessel coagulation, and 2. Conventional vessel coagulation under CO₂ insufflation. Secondary Objectives
- To compare composite forceps use (rescue + prophylactic) between groups.
- To evaluate the frequency of prophylactic-only forceps use.
- To compare total number of forceps applications per procedure.
- To determine differences in intra-procedural bleeding episodes.
- To compare procedural efficiency (procedure time, number of instrument exchanges).
- To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC).
- To compare delayed bleeding rates within 30 days.
- To evaluate overall complication rates (intra- and post-procedural).
- To assess patient-reported outcomes (pain, tolerability). A prospective, randomized, open-label, parallel-group, controlled clinical trial.
Study Arms Intervention Arm: Underwater Coagulation
- Vessel coagulation performed entirely underwater using the Hybrid Knife.
- SWIFT COAG: E3 (89 W) for POEM.
- Physiological saline instilled to completely displace air around the target vessel.
Control Arm: Conventional Coagulation (CO₂ Setting)
- Standard vessel isolation and coagulation under CO₂ insufflation.
- SWIFT COAG: E3 (89 W) for POEM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Under Water Coagulation | – | Other: Under Water Preventive CoagulationIntervention Arm: Underwater Coagulation * Vessel coagulation performed entirely underwater using the Hybrid Knife. * SWIFT COAG: E3 (89 W) for POEM. * Physiological saline instilled to completely displace air around the target vessel. |
| Conventional Coagulation | – | –Control Arm: Conventional Coagulation (CO₂ Setting) * Standard vessel isolation and coagulation under CO₂ insufflation. * SWIFT COAG: E3 (89 W) for POEM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 (60 in each arm)
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Diagnosis of achalasia or esophageal motility disorder planned for POEM
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Anticoagulant or antithrombotic therapy not safely stoppable
- Known coagulopathy or platelet disorder
- Esophageal/gastric varices
- Previous POEM or Heller's myotomy
- Prior treatment for same condition
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 |
|---|---|---|
| Under Water Preventive CoagulationLeverages water as a conductive medium. Preliminary evidence suggests that: 1. electrosurgical current in water is focalized at the interface of the vessel, 2. allowing a soft sealing of the vessel wall, 3. reducing the risk of vessel rupture or unintended deep thermal injury, 4. and potentially eliminating the need to convert to coagulation forceps. | Other | Under Water Coagulation |
Primary outcome
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
Time frame: 60 minutes
1. Underwater preventive vessel coagulation, and 2. Conventional vessel coagulation under CO₂ insufflation.
9 secondary outcomes
To compare composite forceps use (rescue + prophylactic) between groups.
Time frame: 60 minutes
To evaluate the frequency of prophylactic-only forceps use.
Time frame: 60 minutes
To compare total number of forceps applications per procedure.
Time frame: 60 minutes
To determine differences in intra-procedural bleeding episodes
Time frame: 60 minutes
To compare procedural efficiency (procedure time, number of instrument exchanges
Time frame: 60 minutes
To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC)
Time frame: 24 hours
To compare delayed bleeding rates
Time frame: 30 days
To evaluate overall complication rates (intra- and post-procedural)
Time frame: 24 hours
To assess patient-reported outcomes (pain, tolerability).
Time frame: 72 hours
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 12 May 2026.
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, MD DM study director
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vessel Puncture Site Reaction, 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 3 inclusion and 7 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 12 May 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. 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 (04023378888 ext. 312, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between: (time frame: 60 minutes). 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 12 May 2026.