GallstoneNCT04122261
A Clinical Study of Chinese Domestic Surgical Robot
A study of Gallstone and Cholecystitis, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallstone, Cholecystitis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 18-65 years old, male or female
- 2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3
- 3. BMI 18-30Kg/m2
- 4. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder
- 5. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System
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.
Read the detailed description
To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.
- Conditions
- Gallstone, Cholecystitis
- Being tested
- the MicroHand S endoscopic instrument control system, the da Vinci endoscopic instrument control system
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the MicroHand S endoscopic instrument control systemDevice
Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
the da Vinci endoscopic instrument control systemDevice
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | MicroHand S robotic surgery group Receives: Device: the MicroHand S endoscopic instrument control system |
| control group | Experimental | da Vinci robotic surgery group Receives: Device: the da Vinci endoscopic instrument control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical success rate
The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.
Measured: within 24 hours after operation
Secondary outcomes (9)
The breakage rate of gallbladder
The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage.
Measured: within 12 hours after operation
Comprehensive Complication Index (CCI)
CCI is calculated using online tools provided by http://cci.assessurgery.com. Based on the Clavien-Dindo complications grade system (appendix.1), all complications and adverse events after surgical intervention are taken into consideration. The overall incidence is measured on a scale ranging from 0 (no complication) to 100 (death).
Measured: an average of 5 days after operation
Operative time
The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision.
Measured: within 12 hours after operation
Intraoperative bleeding
The total bleeding volume from the beginning of the operation to the end of the suture of the incision. It can be calculated by measuring the blood volume in the vacuum suction device and weighing the gauze after using them to wipe the bleeding.
Measured: within 12 hours after operation
Postoperative pain
Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the operation, ranging from 0 (no pain) to 10 (maximum pain).
Measured: within 24 hours after operation
Time to first flatus
The time from the end of the operation to the subject's first flatus after surgery.
Measured: an average of 2 days after operation
Surgeon's satisfaction
After the operation, surgeons fill a questionnaire to score the flexibility, intuition and stability of the products, as well as their sense of delay and fatigue when using the products. Each question in the score ranges from 1 to 5 points and the total score is 100.
Measured: within 12 hours after operation
Installation time
The time from the power-on of the products to the end of the connection between trocars and the operative arms.
Measured: preoperation
Hospital stay
The total hospital days of subjects from admission to discharge.
Measured: an average of 5 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start13 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor
- Investigators
- Shaihong Zhu, M.D., Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122261
- Sponsor's protocol ID
- SDWG-NST600S-CT
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2019
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35857076
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System
- ClinicalTrials.gov ID
- NCT04122261
- Acronym / sponsor ID
- SDWG-NST600S-CT
- Conditions
- Gallstone, Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: the MicroHand S endoscopic instrument control systemMicroHand S robotic surgery group |
| control group | Experimental | Device: the da Vinci endoscopic instrument control systemda Vinci robotic surgery group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. 18-65 years old, male or female
- 2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3
- 3. BMI 18-30Kg/m2
- 4. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder
- 5. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the MicroHand S endoscopic instrument control systemUsing the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery. | Device | experimental group |
| the da Vinci endoscopic instrument control systemUsing the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery. | Device | control group |
Primary outcome
surgical success rate
Time frame: within 24 hours after operation
The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.
9 secondary outcomes
The breakage rate of gallbladder
Time frame: within 12 hours after operation
Comprehensive Complication Index (CCI)
Time frame: an average of 5 days after operation
Operative time
Time frame: within 12 hours after operation
Intraoperative bleeding
Time frame: within 12 hours after operation
Postoperative pain
Time frame: within 24 hours after operation
Time to first flatus
Time frame: an average of 2 days after operation
Surgeon's satisfaction
Time frame: within 12 hours after operation
Installation time
Time frame: preoperation
Hospital stay
Time frame: an average of 5 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 35857076Wang 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.
- Individual participant dataSharing planned: No
Related trials for Gallstone
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaihong Zhu, M.D. principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gallstone and Cholecystitis, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical success rate (time frame: within 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.