Obesity and Obesity-related Medical ConditionsESG-FUMANCT06790329
ESG With Fundal Mucosal Ablation
A study testing Endoscopic sleeve gastroplasty with fundal mucosal ablation in people with Obesity and Obesity-related Medical Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). 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?
- Endoscopic sleeve gastroplasty with fundal mucosal ablation
- Type of treatment
- Injection or infusion, 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
- 1 Jan 2025to 31 Dec 2027
- 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 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)
- Previous ESG
- Gastroparesis
- Active smoking
- An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
Show all 19Show fewer
- Gastrointestinal obstruction
- 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. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Shatin
Stephen Ng, +85235052956, stephenng@surgery.cuhk.edu.hk
Stephen Ka Kei Ng, FRCSEd(Gen)
About this study
Official title: Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study
Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure.
Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile.
This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.
- Being tested
- Endoscopic sleeve gastroplasty with fundal mucosal ablation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplasty with fundal mucosal ablationProcedure or surgery
Mucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty with fundal mucosal ablation | Experimental | First part of procedure - endoscopic gastric fundus mucosal ablation Second part of procedure - endoscopic sleeve gastroplasty Receives: Procedure: Endoscopic sleeve gastroplasty with fundal mucosal ablation |
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
Secondary outcomes (14)
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
Technical success rate
successful completion of endoscopic procedures
Measured: 1 day
Serum ghrelin levels
Serum ghrelin levels compared to baseline
Measured: baseline, 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, 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 - (score 0:worst - 100:best)
Measured: baseline, 3,6,12 months
Gastric emptying symptoms
measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Measured: baseline, 3,6,12 months
Eating behaviors
measured by Three-Factor Eating Questionnaire (TFEQ-R21) - (21:worst - 84:best)
Measured: baseline, 3,6,12 months
Fasting glucose level
levels compared to baseline
Measured: baseline, 3,6,12 months
Insulin level
levels compared to baseline
Measured: baseline, 3,6,12 months
HbA1c level
levels compared to baseline
Measured: baseline, 3,6,12 months
hepatic steatosis index
level compared to baseline
Measured: baseline, 3,6,12 months
NAFLD fibrosis
NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
Measured: baseline, 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 posted24 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- NCT06790329
- Sponsor's protocol ID
- CRE-2024.501
- Acronym
- ESG-FUMA
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study
- ClinicalTrials.gov ID
- NCT06790329
- Acronym / sponsor ID
- ESG-FUMA / CRE-2024.501
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jan 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.
Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure.
Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile.
This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients 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 |
|---|---|---|
| Endoscopic sleeve gastroplasty with fundal mucosal ablation | Experimental | Procedure: Endoscopic sleeve gastroplasty with fundal mucosal ablationFirst part of procedure - endoscopic gastric fundus mucosal ablation Second part of procedure - endoscopic sleeve gastroplasty |
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 (19 listed)
- Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- Previous ESG
- Gastroparesis
- Active smoking
- An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
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 sleeve gastroplasty with fundal mucosal ablationMucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed. | Procedure or surgery | Endoscopic sleeve gastroplasty with fundal mucosal ablation |
Primary outcome
Body weight
Time frame: baseline, 1,3,6,12 months
Weight change compared to baseline
14 secondary outcomes
Adverse events
Time frame: within 30 days of procedure
Technical success rate
Time frame: 1 day
Serum ghrelin levels
Time frame: baseline, 3,6,12 months
Blood pressure
Time frame: baseline, 1,3,6,12 months
Lipid profile
Time frame: baseline, 3,6,12 months
Pain scale after procedure
Time frame: 3 days
Change in Quality of Life
Time frame: baseline, 3,6,12 months
Gastric emptying symptoms
Time frame: baseline, 3,6,12 months
Eating behaviors
Time frame: baseline, 3,6,12 months
Fasting glucose level
Time frame: baseline, 3,6,12 months
Insulin level
Time frame: baseline, 3,6,12 months
HbA1c level
Time frame: baseline, 3,6,12 months
hepatic steatosis index
Time frame: baseline, 3,6,12 months
NAFLD fibrosis
Time frame: baseline, 3,6,12 months
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 24 Jan 2025.
- 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.
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 Endoscopic sleeve gastroplasty with fundal mucosal ablation 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 19 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 24 Jan 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 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?
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 Stephen Ng ((852)35052956, 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). 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 24 Jan 2025.