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NCT Number: NCT06790329

ESG With Fundal Mucosal Ablation

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Shatin, Hong Kong

Location status: Recruiting

Location contact

Philip Wai Yan Chiu, FRCSEd(Gen), MD

SUB_INVESTIGATOR

Stephen Ka Kei Ng, FRCSEd(Gen)

PRINCIPAL_INVESTIGATOR

Stephen Ng

CONTACT

[email protected]

+85235052956

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Endoscopic sleeve gastroplasty with fundal mucosal ablation

Procedure

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.

Primary outcomes

  1. Body weight

    Time frame: baseline, 1,3,6,12 months

    Weight change compared to baseline

Secondary outcomes

  1. 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)

  2. Technical success rate

    Time frame: 1 day

    successful completion of endoscopic procedures

  3. Serum ghrelin levels

    Time frame: baseline, 3,6,12 months

    Serum ghrelin levels compared to baseline

  4. Blood pressure

    Time frame: baseline, 1,3,6,12 months

    Blood pressure and anti-hypertensive medication use compared to baseline

  5. Lipid profile

    Time frame: baseline, 3,6,12 months

    Lipid profile compared to baseline

  6. Pain scale after procedure

    Time frame: 3 days

    measured by visual analogue scale (0:no pain - 10:worst pain)

  7. Change in Quality of Life

    Time frame: baseline, 3,6,12 months

    measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best)

  8. Gastric emptying symptoms

    Time frame: baseline, 3,6,12 months

    measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)

  9. Eating behaviors

    Time frame: baseline, 3,6,12 months

    measured by Three-Factor Eating Questionnaire (TFEQ-R21) - (21:worst - 84:best)

  10. Fasting glucose level

    Time frame: baseline, 3,6,12 months

    levels compared to baseline

  11. Insulin level

    Time frame: baseline, 3,6,12 months

    levels compared to baseline

  12. HbA1c level

    Time frame: baseline, 3,6,12 months

    levels compared to baseline

  13. hepatic steatosis index

    Time frame: baseline, 3,6,12 months

    level compared to baseline

  14. NAFLD fibrosis

    Time frame: baseline, 3,6,12 months

    NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Ng

CONTACT

[email protected]

(852)35052956

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study

Acronym: ESG-FUMA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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