Study on the Safety and Efficacy of Domestic Single-Port... | NCT07335731

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

NCT07335731

Sponsor

China-Japan Friendship Hospital

Status

Recruiting

Last Update Posted

Jan 13, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Obesity
Robot Surgery

Interventions

Robot-assisted single-port bariatric surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2025Actual

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Jul 30, 2027Estimated

First Submitted Date

Nov 15, 2025

First Submission Date that Met QC Criteria

Jan 12, 2026

First Posted Date

Jan 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 13, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hua Meng, Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic surgical treatment group	Experimental		Device: Robot-assisted single-port bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot-assisted single-port bariatric surgery	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of weight loss		Postoperative 1 month, 3 months, 6 months, 12months

Secondary Outcomes

Measure	Description	Time Frame
blood pressure		1 month, 3 months, 6 months, and 12 months post-surgery
operation time		Intraoperative
Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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 BMI > 50 kg/m² is a relative contraindication; ⑦ Patients deemed unsuitable for participation in this trial by any other investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SIQi Wang	Contact	18810315722		menghuade@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Friendship Hospital	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided