Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

NCT ID: NCT06676267

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gynecological Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic surgical systems

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

Group Type EXPERIMENTAL

Laparoscopic surgery

Intervention Type PROCEDURE

The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.

Interventions

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Laparoscopic surgery

The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minhui Hua, M.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

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Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minhui Hua, M.D.

Role: CONTACT

13773631198 ext. 051385052222

Facility Contacts

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Minhui Hua

Role: primary

86-13773631198

Other Identifiers

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huaminhui

Identifier Type: -

Identifier Source: org_study_id

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