Pathologic Stage I Gastric Cancer AJCC v8NCT06587152
Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
A study testing Robot-assisted surgery in people with Pathologic Stage I Gastric Cancer AJCC v8 and Colorectal Cancer, run by Cornerstone Robotics at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer
- What is being tested?
- Robot-assisted surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2024to 18 Feb 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years;
- Body Mass Height Index (BMI) 18<BMI<30kg/㎡;
- Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
- Written informed consent.
Who cannot join
- Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
- With other malignancies or a previous history of other malignancies.
- Preoperative imaging suggests that the tumour has distant metastases.
- The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
- Severe bleeding tendencies or coagulopathic disorders.
- With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
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- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
- Women who are pregnant or nursing an infant.
- With severe allergies and suspected or established alcohol, drug or substance addiction.
- Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Clinical Trial to Evaluate the Efficacy and Safety of Endoscopy System for General Surgery, Gynecology and Thoracic Surgery
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
Read the detailed description
The trial was designed using a prospective, multi-centre, single-group target value approach.
For subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.
To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.
- Conditions
- Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy, Radical Hysterectomy
- Being tested
- Robot-assisted surgery
- Keywords
- distal gastric cancer, radical surgery, colorectal cancer, oesophageal cancer, hepatectomy, radical hysterectomy
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted surgeryProcedure or surgery
Surgery with the Cornerstone Surgical Robot.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted surgery | Experimental | Robot-assisted thoraco-laparoscopic esophagectomy Receives: Procedure: Robot-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical non-referral rate
Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery.
Measured: during the surgery
Secondary outcomes (4)
The surgeon's operating time
Operative time（minutes）
Measured: during the surgery
Length of postoperative stay
Total number of days the patient was in hospital from the day of surgery to discharge.
Measured: up to 12 weeks
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: during the surgery
Length of stay
The postoperative day when patients complied with the predefined discharge criteria
Measured: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Jan 2024
- Primary completion12 Sep 2024 (estimated)
- Study completion18 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathologic Stage I Gastric Cancer AJCC v8Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornerstone Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiujun Cai, MD, Principal investigator, President of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587152
- Sponsor's protocol ID
- F-00359-002
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4.
PubMed 25670040Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10.
PubMed 33299282
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of Endoscopy System for General Surgery, Gynecology and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06587152
- Acronym / sponsor ID
- F-00359-002
- Conditions
- Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy, Radical Hysterectomy
- Keywords
- distal gastric cancer, radical surgery, colorectal cancer, oesophageal cancer, hepatectomy, radical hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cornerstone RoboticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 12 Sep 2024 (estimated)
- Study completion
- 18 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
Detailed description
The trial was designed using a prospective, multi-centre, single-group target value approach.
For subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.
To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted surgery | Experimental | Procedure: Robot-assisted surgeryRobot-assisted thoraco-laparoscopic esophagectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 80 years;
- Body Mass Height Index (BMI) 18<BMI<30kg/㎡;
- Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
- Written informed consent.
Key exclusion criteria (10 listed)
- Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
- With other malignancies or a previous history of other malignancies.
- Preoperative imaging suggests that the tumour has distant metastases.
- The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
- Severe bleeding tendencies or coagulopathic disorders.
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 |
|---|---|---|
| Robot-assisted surgerySurgery with the Cornerstone Surgical Robot. | Procedure or surgery | Robot-assisted surgery |
Primary outcome
Surgical non-referral rate
Time frame: during the surgery
Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery.
4 secondary outcomes
The surgeon's operating time
Time frame: during the surgery
Length of postoperative stay
Time frame: up to 12 weeks
Intraoperative blood loss
Time frame: during the surgery
Length of stay
Time frame: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25670040Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4.
- Background: PubMed 33299282Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10.
- The adoption of robotic systems for gastric cancer surgery has been proven feasible and safe; however, a benefit over the laparoscopic approach has not yet been well-documented.Link provided by the sponsor.
- The open surgeries and more recently minimal invasive surgeries aided by laparoscopic or robotic approaches are employed for rectal cancer treatment procedures.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Xiujun Cai, MD principal investigator
President of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted surgery in people with Pathologic Stage I Gastric Cancer AJCC v8 and Colorectal Cancer, run by Cornerstone Robotics 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
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 non-referral rate (time frame: during the surgery). 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 NCT06587152, which also lists 2 linked publications.
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 19 Sep 2024.