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

January 12, 2026 updated by: Hua Meng, China-Japan Friendship Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic surgical treatment group
Device: Robot-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 1 month, 3 months, 6 months, and 12 months post-surgery
1 month, 3 months, 6 months, and 12 months post-surgery
operation time
Time Frame: Intraoperative
Intraoperative
Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.)
Time Frame: 12 months post-surgery
12 months post-surgery
Physician fatigue level (Visual Analogue Scale)
Time Frame: 1 day after surgery
1 day after surgery
blood sugar
Time Frame: 1 month, 3 months, 6 months, and 12 months post-surgery
1 month, 3 months, 6 months, and 12 months post-surgery
body fat percentage
Time Frame: 1 month, 3 months, 6 months, and 12 months post-surgery
1 month, 3 months, 6 months, and 12 months post-surgery
estimated blood loss
Time Frame: 1 month after surgery
1 month after surgery
conversion to laparoscopic or open surgery
Time Frame: 1 month after surgery
1 month after surgery
30-day reoperation rate
Time Frame: 1 month after surgery
1 month after surgery
30-day readmission rate
Time Frame: 1 month after surgery
1 month after surgery
length of postoperative hospital stay
Time Frame: 1 month after surgery
1 month after surgery
Physician satisfaction level (Net Promoter Score, NPS)
Time Frame: 1 day after surgery
1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-HX-177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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