ClinicalTrials.gg
RecruitingNCT07335731Updated Sep 16, 2026

Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.

An interventional study of Robot-assisted single-port bariatric surgery in Obesity and Robot Surgery, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2025, registered Nov 2025).
  • Started Jul 2025; still recruiting 1 year 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Obesity by China-Japan Friendship Hospital — 8 open to participants now, 8 under way, none of them phase 3. Obesity · China-Japan Friendship Hospital.

Started
2025
with 2 others
No phase
4 of 10
4 open now
Registered
7th of 10
by date

Among the 10 studies in Obesity by China-Japan Friendship Hospital, this one is one of 3 that started in 2025, is one of 4 with no phase, and was the 7th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

8 of the 10 studies in Obesity by China-Japan Friendship Hospital are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This study aims to obtain short-term clinical results on the safety and efficacy of single-port robot-assisted metabolic weight loss surgery, and to provide further evidence for the clinical promotion of single-port robot systems.

03

Conditions studied

  • Obesity
  • Robot Surgery

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ①Overweight or obese patients who meet the criteria for metabolic weight loss surgery, with a ≥ 27.5 kg/m2; ② Patients who understand the purpose of the trial, voluntarily participate in the trial, and sign an form.

Exclusion criteria

Exclusion Criteria:

  • ① Patients who cannot tolerate general anesthesia, such as those with severe heart, lung, or liver dysfunction; ② Patients with severe coagulation disorders; ③ Pregnant patients; ④ Patients with concurrent tumors; ⑤ Patients with extensive and severe abdominal adhesions that prevent the establishment of pneumoperitoneum; ⑥ A > 50 kg/m² is a relative ; ⑦ Patients deemed unsuitable for participation in this trial by any other investigator.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Robotic surgical treatment group

    Device: Robot-assisted single-port bariatric surgery

Interventions

  • DeviceRobot-assisted single-port bariatric surgery

    For overweight or obese patients (BMI≥27.5kg/m2) who meet the indications for metabolic surgery, single-port robot-assisted sleeve gastrectomy or gastric bypass surgery is performed.

06

What researchers measure

Primary outcomes

  1. Percentage of weight loss

    Time frame: Postoperative 1 month, 3 months, 6 months, 12months

Secondary outcomes

  1. blood pressure

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  2. operation time

    Time frame: Intraoperative

  3. Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.)

    Time frame: 12 months post-surgery

  4. Physician fatigue level (Visual Analogue Scale)

    Time frame: 1 day after surgery

  5. blood sugar

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  6. body fat percentage

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  7. estimated blood loss

    Time frame: 1 month after surgery

  8. conversion to laparoscopic or open surgery

    Time frame: 1 month after surgery

  9. 30-day reoperation rate

    Time frame: 1 month after surgery

  10. 30-day readmission rate

    Time frame: 1 month after surgery

  11. length of postoperative hospital stay

    Time frame: 1 month after surgery

  12. Physician satisfaction level (Net Promoter Score, NPS)

    Time frame: 1 day after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Apr 2027, 21 months after the start.

Of 3,685 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 21 months is close to that.

Counting every sponsor, half of 3,848 studies reached it within 22 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2025
First posted
Jan 13, 2026
StartActual
Jul 10, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
Jul 30, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07335731
Responsible party
Hua Meng (Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital, China-Japan Friendship Hospital) — Principal investigator
First posted
Jan 13, 2026
Start date
Jul 10, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

SIQi Wang
Contact
menghuade@hotmail.com
18810315722

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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