NCT04122261

Brief Summary

This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 13, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

September 28, 2019

Last Update Submit

October 21, 2021

Conditions

GallstoneCholecystitis

Outcome Measures

Primary Outcomes (1)

  • surgical success rate

    The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.

    within 24 hours after operation

Secondary Outcomes (9)

  • The breakage rate of gallbladder

    within 12 hours after operation

  • Comprehensive Complication Index (CCI)

    an average of 5 days after operation

  • Operative time

    within 12 hours after operation

  • Intraoperative bleeding

    within 12 hours after operation

  • Postoperative pain

    within 24 hours after operation

  • +4 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

MicroHand S robotic surgery group

Device: the MicroHand S endoscopic instrument control system

control group

EXPERIMENTAL

da Vinci robotic surgery group

Device: the da Vinci endoscopic instrument control system

Interventions

the MicroHand S endoscopic instrument control systemDEVICE

Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

experimental group
the da Vinci endoscopic instrument control systemDEVICE

Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

control group

Eligibility Criteria

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

You may qualify if:

  • \. 18-65 years old, male or female
  • American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3
  • \. BMI 18-30Kg/m2
  • \. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder
  • \. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form

You may not qualify if:

  • Participating in any other clinical trial within 30 days before signing the informed consent form
  • Pregnancy or lactation
  • With a history of epilepsy or psychosis
  • With a history of previous operations at related sites
  • Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation
  • Severe liver and kidney insufficiency such as cirrhosis and renal failure
  • Acute cholecystitis lasting for more than 72 hours, acute cholecystitis with severe complications such as cholecystitis, gangrene, perforation, etc., and gallbladder thickness thicker than 10 mm
  • Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice
  • Gallbladder cancer or protuberant lesions are suspected to be cancerous
  • Severe allergic constitution and suspected or identified addicts to alcohol or drugs
  • Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases
  • Other situations that researchers consider it inappropriate to participate in this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (1)

  • Wang G, Yi B, Li Z, Zhu L, Hao L, Zeng Y, Zhu S. Micro-Hand Robot-Assisted Versus da Vinci Robot-Assisted Cholecystectomy: A Multi-centre, Randomized Controlled Trial. World J Surg. 2022 Nov;46(11):2632-2641. doi: 10.1007/s00268-022-06668-w. Epub 2022 Jul 20.

    PMID: 35857076DERIVED

MeSH Terms

Conditions

GallstonesCholecystitis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shaihong Zhu, M.D.

    The Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2019

First Posted

October 10, 2019

Study Start

October 13, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)