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Obesity, MildNCT07186959

EGPSS for Weight Management in an in Vivo Human Model

A study testing endoscopic gastric purse-string suturing in people with Obesity, Mild, run by Liu Yan at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity, Mild
What is being tested?
endoscopic gastric purse-string suturing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Jul 2024to 31 Dec 2025
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

  • Patients with a body mass index (BMI) of 24-35 kg / m²;
  • Patients accepted Lifestyle modifications, pharmacological interventions for weight loss which were unsuccessful or experienced a weight rebound;
  • Patients willing to loss weight;
  • Obese patients with metabolic disorders.

Who cannot join

  • Women who are planning to conceive, pregnant, or breastfeeding;
  • Patients who are suffering from severe organ failure requiring hospitalization;
  • Patients who have undergone gastrectomy;
  • Patients allergic to anesthetics.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100071

Other trials in China

About this study

Official title: A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and other complications. To restrain fundic expansion while minimizing surgical trauma and preserving reversibility, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce gastric volume. This procedure may be suitable for short-term weight management. Safety and feasibility were demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Read the detailed description

The global prevalence of obesity has increased over the past five decades. Endoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management and have emerged as promising alternatives for treating obesity and related metabolic disorders (including type 2 diabetes and nonalcoholic fatty liver disease). Christopher et al. reported that ablation of the gastric fundus mucosa induces mucosal fibrosis; the resulting fibrotic tissue impedes fundic expansion and promotes satiety. However, fundic mucosal ablation may cause extensive and irreversible injury, increasing the risks of perforation, infection, bleeding, and other complications. A minimally invasive endoscopic therapy that inhibits fundic expansion while minimizing surgical trauma and preserving reversibility is therefore desirable.

Based on this rationale, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce the volume of the gastric fundus. EGPSS employs a specially designed endoclip in combination with an endoloop to appose the fundic mucosa and restrict fundic expansion. This procedure may be suitable for short-term weight management. Safety and feasibility have been demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Conditions
Obesity, Mild
Being tested
endoscopic gastric purse-string suturing
Keywords
obesity, endoscopic bariatric and metabolic therapy, bariatric surgery
Medical subject headings
Obesity, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic gastric purse-string suturingProcedure or surgery

    A dual-tail endoloop will be introduced into the stomach with endoscopic forceps, and will be secured to the gastric wall using endoscopic clips. An endoscope hook was used to tighten both tails of the endoloop until all the clips converged.

Study groups in NCT07186959
Study groupRoleWhat they receive
Operation groupExperimentalPatients will undergo endoscopic gastric purse-string suturing procedure under endoscope by skilled endoscopist
Receives: Procedure: endoscopic gastric purse-string suturing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Total Weight Loss (%TWL) measured by calibrated digital scale

    Body weight recorded using a calibrated digital scale (kg). %TWL calculated as (baselineweight-follow-upweight)÷baselineweight × 100%. Measurements obtained under fasting conditions, light clothing, no shoes.

    Measured: Baseline and 3 months post-procedure

Secondary outcomes (6)

  1. Percent Excess Weight Loss (%EWL) measured by calibrated digital scale

    %EWL calculated as (baselineweight-follow-upweight)÷(baselineweight-idealweightatBMI25kg/m

    ) × 100%.

    Measured: Baseline and 3 months

  2. Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal

    Satiety assessed using a 100-mm VAS (0 = not at all, 100 = extremely) at 0, 15, 30, 60 minutes after a 400-kcal standardized liquid meal; area under the curve (AUC) computed.

    Measured: Baseline and 3 months

  3. Gastric fundus volume (magnetic resonance imaging, MRI)

    Fundic volume quantified by MRI volumetry during a standardized water-challenge protocol; primary read by a blinded radiologist; volume reported in mL and Δ from baseline.

    Measured: Baseline and 3 months

  4. Fasting plasma ghrelin and leptin (ELISA)

    Morning fasting venous samples analyzed by validated ELISA; concentrations reported in pg/mL (ghrelin) and ng/mL (leptin).

    Measured: Baseline and 3 months

  5. Insulin resistance (HOMA-IR)

    HOMA-IR calculated from fasting glucose (mmol/L) and insulin (µU/mL): insulin × glucose ÷ 22.5.

    Measured: Baseline and 3 months

  6. Procedure-related adverse events (ASGE lexicon severity grading)

    All adverse events captured and coded using the ASGE lexicon with severity grade and relatedness adjudicated by the safety monitor.

    Measured: Day 0 to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Jul 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186959
Sponsor's protocol ID
EGPSS for weight management
Status last verified
Sep 2025
First submitted
11 Sep 2025
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.

    PubMed 30814686

  • Maselli DB, Donnangelo LL, Coan B, McGowan CE. How to establish an endoscopic bariatric practice. World J Gastrointest Endosc. 2024 Apr 16;16(4):178-186. doi: 10.4253/wjge.v16.i4.178.

    PubMed 38680199

  • Simons M, Sharaiha RZ. Updates in metabolic bariatric endoscopy. Dig Endosc. 2024 Feb;36(2):107-115. doi: 10.1111/den.14633. Epub 2023 Aug 9.

    PubMed 37405807

  • Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14.

    PubMed 36241388

Questions about this trial

What is this clinical trial studying?

A study testing endoscopic gastric purse-string suturing in people with Obesity, Mild, run by Liu Yan at 1 site in China.

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 4 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 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 China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Total Weight Loss (%TWL) measured by calibrated digital scale (time frame: Baseline and 3 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186959, which also lists 4 linked publications.

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 22 Sep 2025.

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