NCT07524699

Brief Summary

The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery. The main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery. Participants will: Undergo remote or local robotic liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Jul 2028

First Submitted

Initial submission to the registry

March 28, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 16, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

May 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 28, 2026

Last Update Submit

May 13, 2026

Conditions

Liver Diseases

Keywords

Remote SurgeryLiver SurgeryRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Textbook outcome in liver surgery

    The textbook outcome in liver surgery is defined as the absence of intraoperative incidents of grade 2 or higher (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery),30 severe complications (Clavien-Dindo grade III or higher), postoperative reintervention (ie, surgical, endoscopic, or radiologic), readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin (ie, 1 mm or more tumor-free margin).

    6 weeks

Secondary Outcomes (17)

  • Surgery Success rate

    1 day

  • Overall complication rate

    6 weeks

  • Operation Time

    During surgery

  • Console Time

    During surgery

  • Blood loss

    During surgery

  • +12 more secondary outcomes

Study Arms (2)

Local Surgery

ACTIVE COMPARATOR

The patients in this arm (group) will undergo local liver surgery according to random allocation.

Device: Local Liver Surgery

Remote Surgery

EXPERIMENTAL

The patients in this arm (group) will undergo remote liver surgery according to random allocation.

Device: Remote Liver Surgery

Interventions

Remote Liver SurgeryDEVICE

The patients in this arm will undergo remote liver surgery.

Remote Surgery
Local Liver SurgeryDEVICE

The patients in this arm will undergo local liver surgery.

Local Surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: 18-75 years old (inclusive), gender not restricted;
  • BMI: 18-30 Kg/m2;
  • Relevant indications for liver surgery;
  • Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;
  • Willing to cooperate and complete follow-up and related subsequent examinations;
  • Voluntary to sign the informed consent form;
  • Indocyanine green 15-minute retention rate (ICG-R15) \< 15%, and liver function Child-Pugh grade is A.

You may not qualify if:

  • Patients with severe circulatory system diseases who cannot tolerate surgery;
  • Pregnant or lactating women;
  • Patients with a history of epilepsy or mental illness;
  • Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;
  • Patients who cannot understand the research requirements or who cannot complete the research follow-up;
  • Patients considered unsuitable to participate in this trial by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Peng Zhu, Medicine Doctor

CONTACT

+86-13907170712zhupeng@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Surgery

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 13, 2026

Study Start

May 16, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

May 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

If the readers want to learn more about the study, please send an e-mail to Doctor Peng Zhu.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CN(1)