Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Gynecological Cancer

Treatments: Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06676267

huaminhui

Details and patient eligibility

About

Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

Full description

This clinical study adopts a prospective, single-center, single-arm exploratory design. Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

The research process consists of three stages: the screening phase, the treatment phase and the follow-up phase. The screening phase: On the premise of meeting the inclusion and exclusion criteria, patients who voluntarily participate in robot-assisted surgery are planned to be included. Obtain written informed consent from the subjects, collect clinical data (which may include previous medical examination results), and complete relevant examinations. The treatment phase: The laparoscopic surgical system is combined with 5G network and communication technology for the surgical operation process. The follow-up phase: The physician's observational follow-up of the subjects in the study will continue up to one month post-surgery, and may be extended if necessary. During these three phases, subjects will need to undergo some medical observations or examinations to assess safety and efficacy indicators.

Enrollment: 5 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who require endoscopic surgery
• Voluntarily participate in this study and sign informed consent in writing

Exclusion criteria

• Patients with malignant tumors with clinical stage IV
• Those who require emergency surgery
• Presence of active bleeding, severe abnormal coagulopathy (prothrombin time (PT) or international normalized ratio (INR) greater than 1.5 times the upper limit of normal), or platelet count < 80×10^9/L
• Patient has severe cardiovascular or circulatory disease and cannot tolerate surgery
• Participated in other clinical trials in the past 1 month
• Inability to understand trial requirements, or inability to complete the study follow-up plan
• Other conditions that are considered by the investigator to be inappropriate for enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

laparoscopic surgical systems

Experimental group

Description:

Using the Toumai laparoscopic surgical system for gynecological surgical treatment, and combining with 5G communication technology to carry out remote surgical treatment.

Treatment:

Procedure: Laparoscopic surgery