Colorectal CancerNCT07382635
Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery
An observational study of Colorectal Cancer and Esophageal Cancer, run by Cornerstone Robotics.
Trial summary
Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Hepatectomy
- What is being tested?
- Robot-assisted surgery
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Aug 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
Who may be able to join
- Age ≥ 18 and ≤ 80 years;
- Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
- Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.
- Willing to cooperate with and complete trial follow-ups and relevant examinations.
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.
- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
- Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
About this study
Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery
Read the detailed description
This trial adopts a prospective, multicenter, single-arm objective value design.For subjects scheduled to undergo thoracoabdominal endoscopic surgery system-assisted laparoscopic surgeries in the departments of urology, general surgery, gynecology and thoracic surgery, the thoracoabdominal endoscopic surgery system developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. will be used to perform remote laparoscopic surgeries in the above four departments, and the efficacy and safety of the investigational medical device in the treatment of remote laparoscopic surgeries in these four departments will be evaluated.
- Being tested
- Robot-assisted surgery
- Keywords
- distal gastric cancer, radical surgery, colorectal 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 surgeryDevice
Surgery with the Cornerstone Surgical Robot.
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 (3)
The surgeon's operating time
Operative time（minutes）
Measured: during the surgery
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 posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
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 Colorectal CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cornerstone Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382635
- Sponsor's protocol ID
- F-00300-003
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai EC, Tang CN. Long-term Survival Analysis of Robotic Versus Conventional Laparoscopic Hepatectomy for Hepatocellular Carcinoma: A Comparative Study. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):162-6. doi: 10.1097/SLE.0000000000000254.
PubMed 27031650
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07382635
- Acronym / sponsor ID
- F-00300-003
- Keywords
- distal gastric cancer, radical surgery, colorectal cancer, hepatectomy, radical hysterectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Cornerstone RoboticsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Feb 2026 (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 the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery
Detailed description
This trial adopts a prospective, multicenter, single-arm objective value design.For subjects scheduled to undergo thoracoabdominal endoscopic surgery system-assisted laparoscopic surgeries in the departments of urology, general surgery, gynecology and thoracic surgery, the thoracoabdominal endoscopic surgery system developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. will be used to perform remote laparoscopic surgeries in the above four departments, and the efficacy and safety of the investigational medical device in the treatment of remote laparoscopic surgeries in these four departments will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 80 years;
- Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
- Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.
- Willing to cooperate with and complete trial follow-ups and relevant examinations.
Key exclusion criteria (8 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. | Device | – |
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.
3 secondary outcomes
The surgeon's operating time
Time frame: during the surgery
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 27031650Lai EC, Tang CN. Long-term Survival Analysis of Robotic Versus Conventional Laparoscopic Hepatectomy for Hepatocellular Carcinoma: A Comparative Study. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):162-6. doi: 10.1097/SLE.0000000000000254.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Esophageal Cancer, run by Cornerstone Robotics.
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 8 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 NCT07382635, 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 3 Feb 2026.