Obesity and Obesity-related Medical ConditionsBEAM pilotNCT06622382
BEAM for Weight Loss - a Pilot Study
A study testing Bariatric endoscopic antral myotomy in people with Obesity and Obesity-related Medical Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Bariatric endoscopic antral myotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Sep 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
- failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination
Who cannot join
- Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- Gastroparesis
- Active smoking
- An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
- Gastrointestinal obstruction
Show all 18Show fewer
- Use of any medication that may interfere with weight loss or gastric emptying
- Severe coagulopathy
- Esophageal or gastric varices and/or portal hypertensive gastropathy
- Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.)
- Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
- Malignancy
- Pregnant or breast feeding
- Patients not fit for general anesthesia
- ASA grade IV or V
- Mental or psychiatric disorder; Drug or alcohol addiction
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Shatin
Stephen Ng, FRCSEd(Gen), +85235052956, stephenng@surgery.cuhk.edu.hk
Jenny Ho, +85235052956, jennyho@surgery.cuhk.edu.hk
About this study
Official title: Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.
- Being tested
- Bariatric endoscopic antral myotomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric endoscopic antral myotomyProcedure or surgery
A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haemostasis is confirmed.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric endoscopic antral myotomy | Experimental | Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Receives: Procedure: Bariatric endoscopic antral myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight change compared to baseline
Measured: baseline, 1,3,6,12 months
Adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: within 30 days of procedure
Secondary outcomes (14)
Technical success rate
successful completion of endoscopic procedures
Measured: 1 day
Serum ghrelin levels
Serum ghrelin levels compared to baseline
Measured: baseline, 1,3,6,12 months
Blood pressure
Blood pressure and anti-hypertensive medication use compared to baseline
Measured: baseline, 1,3,6,12 months
Lipid profile
Lipid profile compared to baseline
Measured: baseline, 1,3,6,12 months
Pain scale after procedure
measured by visual analogue scale (0:no pain - 10:worst pain)
Measured: 3 days
Change in Quality of Life
measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best)
Measured: baseline, 1,6,12 months
Gastric emptying symptoms
measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Measured: baseline, 1,6,12 months
Fasting glucose level
levels compared to baseline
Measured: baseline, 1,3,6,12 months
Insulin level
levels compared to baseline
Measured: baseline, 1,3,6,12 months
HbA1c level
levels compared to baseline
Measured: baseline, 1,3,6,12 months
serum liver parameters
AST, ALT, ALP and GGT level compared to baseline
Measured: baseline, 1,3,6,12 months
hepatic steatosis index
level compared to baseline
Measured: baseline, 1,3,6,12 months
NAFLD fibrosis
NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
Measured: baseline, 1,3,6,12 months
obstructive sleep apnea
Change in sleep quality
Measured: baseline, 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start12 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen KK Ng, Chinese University of Hong Kong
- Investigators
- Stephen Ng, FRCSEd(Gen), Principal investigator, Prince of Wales Hospital, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622382
- Sponsor's protocol ID
- CRE-2024.223
- Acronym
- BEAM pilot
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
- ClinicalTrials.gov ID
- NCT06622382
- Acronym / sponsor ID
- BEAM pilot / CRE-2024.223
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Oct 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.
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric endoscopic antral myotomy | Experimental | Procedure: Bariatric endoscopic antral myotomyBariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
- failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination
Key exclusion criteria (18 listed)
- Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- Gastroparesis
- Active smoking
- An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
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 |
|---|---|---|
| Bariatric endoscopic antral myotomyA mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haemostasis is confirmed. | Procedure or surgery | Bariatric endoscopic antral myotomy |
Primary outcome
Body weight
Time frame: baseline, 1,3,6,12 months
Weight change compared to baseline
Adverse events
Time frame: within 30 days of procedure
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
14 secondary outcomes
Technical success rate
Time frame: 1 day
Serum ghrelin levels
Time frame: baseline, 1,3,6,12 months
Blood pressure
Time frame: baseline, 1,3,6,12 months
Lipid profile
Time frame: baseline, 1,3,6,12 months
Pain scale after procedure
Time frame: 3 days
Change in Quality of Life
Time frame: baseline, 1,6,12 months
Gastric emptying symptoms
Time frame: baseline, 1,6,12 months
Fasting glucose level
Time frame: baseline, 1,3,6,12 months
Insulin level
Time frame: baseline, 1,3,6,12 months
HbA1c level
Time frame: baseline, 1,3,6,12 months
serum liver parameters
Time frame: baseline, 1,3,6,12 months
hepatic steatosis index
Time frame: baseline, 1,3,6,12 months
NAFLD fibrosis
Time frame: baseline, 1,3,6,12 months
obstructive sleep apnea
Time frame: baseline, 1,3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Stephen Ng, FRCSEd(Gen) principal investigator
Prince of Wales Hospital, the Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric endoscopic antral myotomy in people with Obesity and Obesity-related Medical Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 18 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Ng, FRCSEd(Gen) (+85235052956, stephenng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: baseline, 1,3,6,12 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 2 Oct 2024.