An interventional study of MP2000 Thoracoabdominal Endoscopic Surgical System in Endometrial Cancer and Cervical Cancer (Early Detection), sponsored by Women's Hospital School Of Medicine Zhejiang University. Not yet recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 92 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cervical cancer: aged 18 to 70 years; or endometrial cancer: aged 18 to 80 years.
: 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 form.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo remote robotic surgery for gynecologic malignancies using the MP2000 thoracoabdominal endoscopic surgical system. The surgeon will operate from a remote console.
Device: MP2000 Thoracoabdominal Endoscopic Surgical System
articipants will undergo conventional local robotic surgery for gynecologic malignancies using the same MP2000 thoracoabdominal endoscopic surgical system at the bedside.
Device: MP2000 Thoracoabdominal Endoscopic Surgical System
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).
Surgical Success Rate
The proportion of participants who complete the planned surgical procedure without conversion to open surgery or other major intraoperative deviations.
Time frame: 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.
Time frame: Up to 30 days after surgery
Overall Complication Rate
The proportion of participants who experience any postoperative complication, regardless of severity, including both surgical and medical complications.
Time frame: 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.
Time frame: Perioperative
Estimated Intraoperative Blood Loss (mL)
The estimated volume of blood lost during the surgical procedure, measured in milliliters.
Time frame: Perioperative
Positive Margin Rate (%)
The proportion of participants with positive surgical margins confirmed by postoperative pathological examination.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative
Length of Hospital Stay (days)
The total number of days from admission to discharge after the surgical procedure.
Time frame: Perioperative
Transfusion Rate (%)
The proportion of participants who require blood transfusion during or after the surgical procedure.
Time frame: Perioperative
Readmission Rate (%)
The proportion of participants who are readmitted to the hospital for any cause after initial discharge.
Time frame: Up to 30 days after discharge
Reoperation Rate (%)
The proportion of participants who require a second surgical procedure related to the initial operation.
Time frame: Up to 30 days after surgery
Mortality Rate (%)
The proportion of participants who die from any cause during the study period.
Time frame: 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.
Time frame: Perioperative
Adverse Event Rate
The proportion of participants who experience any adverse event during the study period.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative
Overall Survival (OS)
The time from randomization to death from any cause.
Time frame: 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.
Time frame: Up to 5 years
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Women's Hospital School Of Medicine Zhejiang University