Endometrial CancerRRS-GYN-RCTNCT07896720
Remote Robotic Surgery for Gynecologic Cancer: A Safety and Effectiveness Study
A study testing MP2000 Thoracoabdominal Endoscopic Surgical System in people with Endometrial Cancer and Cervical Cancer (Early Detection), run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
This investigator-initiated, multicenter, single-blind, randomized controlled clinical study is designed to evaluate the safety and effectiveness of the MP2000 thoracoabdominal endoscopic surgical system (Shenzhen Jingfeng Medical Technology Co., Ltd.) when used for remote robotic surgery in patients with gynecologic… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Cancer (Early Detection)
- What is being tested?
- MP2000 Thoracoabdominal Endoscopic Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Sep 2029
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical cancer: aged 18 to 70 years; or endometrial cancer: aged 18 to 80 years.
- BMI: 18 to 40 kg/m². Histopathologically confirmed endometrial cancer or cervical cancer with an indication for surgery.
- Physiologically suitable for laparoscopic surgery. Willing to comply with and complete study follow-up and related examinations. Voluntary signing of the informed consent form.
Who cannot join
- Severe cardiovascular or circulatory disease that makes surgery intolerable. Fertility-sparing requirement. Pregnancy or lactation. History of epilepsy or psychiatric disorders. Severe allergic constitution, or suspected or confirmed alcohol or drug addiction.
- Inability to understand study requirements or complete the follow-up schedule. Any other condition deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Single-Blind, Randomized Controlled Study on the Safety and Efficacy of Remote Robotic Surgery for Gynecologic Malignancies
This investigator-initiated, multicenter, single-blind, randomized controlled clinical study is designed to evaluate the safety and effectiveness of the MP2000 thoracoabdominal endoscopic surgical system (Shenzhen Jingfeng Medical Technology Co., Ltd.) when used for remote robotic surgery in patients with gynecologic malignancies. By comparing remote robotic surgery with local robotic surgery, the study will assess clinical outcomes including postoperative recovery, the incidence of complications, and the length of hospital stay, thereby providing clinical evidence on the safety and efficacy of remote robotic surgery versus conventional local robotic surgery.
Read the detailed description
Background:
Remote robotic surgery may enable experienced surgeons to perform complex gynecologic oncologic procedures across geographical distances. However, clinical evidence on the safety and effectiveness of remote robotic surgery compared with conventional local robotic surgery remains limited. This investigator-initiated study is designed to evaluate the safety and effectiveness of the MP2000 thoracoabdominal endoscopic surgical system for remote gynecologic tumor surgery.
Study Design:
This is a multicenter, single-blind, randomized controlled trial. Participants will be randomized in a 1:1 ratio to undergo either remote robotic surgery (experimental group) or local robotic surgery (control group) using the MP2000 system. The study will enroll patients with endometrial cancer and cervical cancer as two separate cohorts, with 46 patients planned for each cohort (23 in the experimental group and 23 in the control group). The sample size was calculated based on a non-inferiority design using PASS 16 software, with a one-sided significance level of α = 0.025, a power of 80% (β = 0.2), a non-inferiority margin of Δ = -20%, and an assumed surgical success rate of 95% in both groups. A dropout rate of approximately 15% was taken into consideration.
Statistical Analysis:
The sample size was determined in accordance with the Guidelines for Clinical Study Design of Medical Devices, through joint discussion among the clinical research institution, the principal investigator, the statistician, and participating centers, using a non-inferiority sample size calculation method.
Statistical analysis will be performed using SPSS version 20 or above, and sample size calculation will be performed using PASS 16. Effectiveness outcomes will be analyzed in both the full analysis set (FAS) and the per-protocol set (PPS), while safety outcomes will be analyzed in the safety set (SS).
Quantitative variables will be described using mean, standard deviation, median, minimum, maximum, lower quartile (Q1), and upper quartile (Q3). Categorical variables will be described using counts and percentages.
Completion status and demographic characteristics will be analyzed based on the FAS. Enrollment and completion numbers at each center will be summarized, and a list of dropout cases will be provided, including dataset size, distribution of cases across centers, overall dropout rate comparison, and detailed reasons for non-completion. Demographic characteristics (age, height, vital signs, etc.), medical history, medication history, and device usage will be described.
The primary effectiveness outcome will be analyzed based on the FAS and PPS. The primary safety outcome will be analyzed based on the FAS and PPS. Secondary effectiveness outcomes will be analyzed based on the FAS and PPS. Secondary safety outcomes will be analyzed based on the SS. The incidence and number of patients with product-related complications, system failures, adverse events, device-related adverse events, serious adverse events, and device-related serious adverse events will be listed and described.
- Being tested
- MP2000 Thoracoabdominal Endoscopic Surgical System
- Keywords
- Remote Robotic Surgery, Endometrial Cancer, Cervical Cancer, Randomized Controlled Trial
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP2000 Thoracoabdominal Endoscopic Surgical SystemDevice
The MP2000 is a thoracoabdominal endoscopic surgical system developed by Shenzhen Jingfeng Medical Technology Co., Ltd. It is a robotic surgical system used to perform minimally invasive surgery for gynecologic malignancies, including endometrial cancer and cervical cancer. In this study, it will be used for both remote robotic surgery (experimental group) and conventional local robotic surgery (control group).
| Study group | Role | What they receive |
|---|---|---|
| Remote Robotic Surgery Group | Experimental | Participants will undergo remote robotic surgery for gynecologic malignancies using the MP2000 thoracoabdominal endoscopic surgical system. The surgeon will operate from a remote console. Receives: Device: MP2000 Thoracoabdominal Endoscopic Surgical System |
| Local Robotic Surgery Group | Active comparator | articipants will undergo conventional local robotic surgery for gynecologic malignancies using the same MP2000 thoracoabdominal endoscopic surgical system at the bedside. Receives: Device: MP2000 Thoracoabdominal Endoscopic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success Rate
The proportion of participants who complete the planned surgical procedure without conversion to open surgery or other major intraoperative deviations.
Measured: Perioperative
Incidence of Grade 3 or Higher Complications
The proportion of participants who experience grade 3 or higher postoperative complications, as defined by the Clavien-Dindo classification.
Measured: Up to 30 days after surgery
Secondary outcomes (17)
Overall Complication Rate
The proportion of participants who experience any postoperative complication, regardless of severity, including both surgical and medical complications.
Measured: Up to 30 days after surgery
Operative Time (min)
The total duration of the surgical procedure, measured in minutes from skin incision to skin closure.
Measured: Perioperative
Estimated Intraoperative Blood Loss (mL)
The estimated volume of blood lost during the surgical procedure, measured in milliliters.
Measured: Perioperative
Positive Margin Rate (%)
The proportion of participants with positive surgical margins confirmed by postoperative pathological examination.
Measured: Up to 30 days after surgery
Visual Analogue Scale (VAS) Pain Score
The intensity of postoperative pain assessed using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores indicate a worse outcome.
Measured: Postoperative Day 1
Surgeon Satisfaction Score
The level of satisfaction reported by the operating surgeon regarding the surgical system and procedure, assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate a better outcome.
Measured: Perioperative
Length of Hospital Stay (days)
The total number of days from admission to discharge after the surgical procedure.
Measured: Perioperative
Transfusion Rate (%)
The proportion of participants who require blood transfusion during or after the surgical procedure.
Measured: Perioperative
Readmission Rate (%)
The proportion of participants who are readmitted to the hospital for any cause after initial discharge.
Measured: Up to 30 days after discharge
Reoperation Rate (%)
The proportion of participants who require a second surgical procedure related to the initial operation.
Measured: Up to 30 days after surgery
Mortality Rate (%)
The proportion of participants who die from any cause during the study period.
Measured: Through study completion, an average of 2 years
Device Defect Rate
The proportion of participants who experience any malfunction, defect, or failure of the MP2000 surgical system during the procedure.
Measured: Perioperative
Adverse Event Rate
The proportion of participants who experience any adverse event during the study period.
Measured: Through study completion, an average of 2 years
Serious Adverse Event Rate
The proportion of participants who experience any serious adverse event during the study period.
Measured: Up to 1 year
Remote Operation Evaluation
Assessment of the performance and reliability of the remote operation, including signal latency, operational stability, and surgeon feedback, using a standardized evaluation form.
Measured: Perioperative
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: Up to 5 years
Disease-Free Survival (DFS)
The time from randomization to the first occurrence of disease recurrence or death from any cause, whichever comes first.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to undergo either remote robotic surgery (experimental group) or local robotic surgery (control group). Randomization will be stratified by study center and cancer type (endometrial cancer or cervical cancer).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Hui, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896720
- Sponsor's protocol ID
- IRB-20260296-R
- Acronym
- RRS-GYN-RCT
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This is an investigator-initiated, multicenter study, and the data are owned collectively by the participating institutions. Data sharing is subject to the data-sharing agreements among the participating sites, and the informed consent form does not include provisions for sharing individual participant data with researchers outside the study group. In addition, the data contain sensitive clinical information that is protected by ethical and privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Blind, Randomized Controlled Study on the Safety and Efficacy of Remote Robotic Surgery for Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT07896720
- Acronym / sponsor ID
- RRS-GYN-RCT / IRB-20260296-R
- Keywords
- Remote Robotic Surgery, Endometrial Cancer, Cervical Cancer, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 Oct 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.
This investigator-initiated, multicenter, single-blind, randomized controlled clinical study is designed to evaluate the safety and effectiveness of the MP2000 thoracoabdominal endoscopic surgical system (Shenzhen Jingfeng Medical Technology Co., Ltd.) when used for remote robotic surgery in patients with gynecologic malignancies. By comparing remote robotic surgery with local robotic surgery, the study will assess clinical outcomes including postoperative recovery, the incidence of complications, and the length of hospital stay, thereby providing clinical evidence on the safety and efficacy of remote robotic surgery versus conventional local robotic surgery.
Detailed description
Background:
Remote robotic surgery may enable experienced surgeons to perform complex gynecologic oncologic procedures across geographical distances. However, clinical evidence on the safety and effectiveness of remote robotic surgery compared with conventional local robotic surgery remains limited. This investigator-initiated study is designed to evaluate the safety and effectiveness of the MP2000 thoracoabdominal endoscopic surgical system for remote gynecologic tumor surgery.
Study Design:
This is a multicenter, single-blind, randomized controlled trial. Participants will be randomized in a 1:1 ratio to undergo either remote robotic surgery (experimental group) or local robotic surgery (control group) using the MP2000 system. The study will enroll patients with endometrial cancer and cervical cancer as two separate cohorts, with 46 patients planned for each cohort (23 in the experimental group and 23 in the control group). The sample size was calculated based on a non-inferiority design using PASS 16 software, with a one-sided significance level of α = 0.025, a power of 80% (β = 0.2), a non-inferiority margin of Δ = -20%, and an assumed surgical success rate of 95% in both groups. A dropout rate of approximately 15% was taken into consideration.
Statistical Analysis:
The sample size was determined in accordance with the Guidelines for Clinical Study Design of Medical Devices, through joint discussion among the clinical research institution, the principal investigator, the statistician, and participating centers, using a non-inferiority sample size calculation method.
Statistical analysis will be performed using SPSS version 20 or above, and sample size calculation will be performed using PASS 16. Effectiveness outcomes will be analyzed in both the full analysis set (FAS) and the per-protocol set (PPS), while safety outcomes will be analyzed in the safety set (SS).
Quantitative variables will be described using mean, standard deviation, median, minimum, maximum, lower quartile (Q1), and upper quartile (Q3). Categorical variables will be described using counts and percentages.
Completion status and demographic characteristics will be analyzed based on the FAS. Enrollment and completion numbers at each center will be summarized, and a list of dropout cases will be provided, including dataset size, distribution of cases across centers, overall dropout rate comparison, and detailed reasons for non-completion. Demographic characteristics (age, height, vital signs, etc.), medical history, medication history, and device usage will be described.
The primary effectiveness outcome will be analyzed based on the FAS and PPS. The primary safety outcome will be analyzed based on the FAS and PPS. Secondary effectiveness outcomes will be analyzed based on the FAS and PPS. Secondary safety outcomes will be analyzed based on the SS. The incidence and number of patients with product-related complications, system failures, adverse events, device-related adverse events, serious adverse events, and device-related serious adverse events will be listed and described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to undergo either remote robotic surgery (experimental group) or local robotic surgery (control group). Randomization will be stratified by study center and cancer type (endometrial cancer or cervical cancer).
| Arm | Type | Receives |
|---|---|---|
| Remote Robotic Surgery Group | Experimental | Device: MP2000 Thoracoabdominal Endoscopic Surgical SystemParticipants will undergo remote robotic surgery for gynecologic malignancies using the MP2000 thoracoabdominal endoscopic surgical system. The surgeon will operate from a remote console. |
| Local Robotic Surgery Group | Active comparator | Device: MP2000 Thoracoabdominal Endoscopic Surgical Systemarticipants will undergo conventional local robotic surgery for gynecologic malignancies using the same MP2000 thoracoabdominal endoscopic surgical system at the bedside. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cervical cancer: aged 18 to 70 years; or endometrial cancer: aged 18 to 80 years.
- BMI: 18 to 40 kg/m². Histopathologically confirmed endometrial cancer or cervical cancer with an indication for surgery.
- Physiologically suitable for laparoscopic surgery. Willing to comply with and complete study follow-up and related examinations. Voluntary signing of the informed consent form.
Key exclusion criteria (2 listed)
- Severe cardiovascular or circulatory disease that makes surgery intolerable. Fertility-sparing requirement. Pregnancy or lactation. History of epilepsy or psychiatric disorders. Severe allergic constitution, or suspected or confirmed alcohol or drug addiction.
- Inability to understand study requirements or complete the follow-up schedule. Any other condition deemed unsuitable for participation by the investigator.
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 |
|---|---|---|
| MP2000 Thoracoabdominal Endoscopic Surgical SystemThe MP2000 is a thoracoabdominal endoscopic surgical system developed by Shenzhen Jingfeng Medical Technology Co., Ltd. It is a robotic surgical system used to perform minimally invasive surgery for gynecologic malignancies, including endometrial cancer and cervical cancer. In this study, it will be used for both remote robotic surgery (experimental group) and conventional local robotic surgery (control group). | Device | Local Robotic Surgery Group, Remote Robotic Surgery Group |
Primary outcome
Surgical Success Rate
Time frame: Perioperative
The proportion of participants who complete the planned surgical procedure without conversion to open surgery or other major intraoperative deviations.
Incidence of Grade 3 or Higher Complications
Time frame: Up to 30 days after surgery
The proportion of participants who experience grade 3 or higher postoperative complications, as defined by the Clavien-Dindo classification.
17 secondary outcomes
Overall Complication Rate
Time frame: Up to 30 days after surgery
Operative Time (min)
Time frame: Perioperative
Estimated Intraoperative Blood Loss (mL)
Time frame: Perioperative
Positive Margin Rate (%)
Time frame: Up to 30 days after surgery
Visual Analogue Scale (VAS) Pain Score
Time frame: Postoperative Day 1
Surgeon Satisfaction Score
Time frame: Perioperative
Length of Hospital Stay (days)
Time frame: Perioperative
Transfusion Rate (%)
Time frame: Perioperative
Readmission Rate (%)
Time frame: Up to 30 days after discharge
Reoperation Rate (%)
Time frame: Up to 30 days after surgery
Mortality Rate (%)
Time frame: Through study completion, an average of 2 years
Device Defect Rate
Time frame: Perioperative
Adverse Event Rate
Time frame: Through study completion, an average of 2 years
Serious Adverse Event Rate
Time frame: Up to 1 year
Remote Operation Evaluation
Time frame: Perioperative
Overall Survival (OS)
Time frame: Up to 5 years
Disease-Free Survival (DFS)
Time frame: Up to 5 years
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This is an investigator-initiated, multicenter study, and the data are owned collectively by the participating institutions. Data sharing is subject to the data-sharing agreements among the participating sites, and the informed consent form does not include provisions for sharing individual participant data with researchers outside the study group. In addition, the data contain sensitive clinical information that is protected by ethical and privacy regulations.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MP2000 Thoracoabdominal Endoscopic Surgical System in people with Endometrial Cancer and Cervical Cancer (Early Detection), run by Women's Hospital School Of Medicine Zhejiang University.
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 3 inclusion and 2 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 27 Oct 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?
Contact Hui Wang (0086-13995688338, wang71hui@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Success Rate (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.