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Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery

NCT ID: NCT06286150

Last Updated: 2024-02-29

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2027-07-15

Brief Summary

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Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery.

Detailed Description

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Conditions

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Lung Cancer

Keywords

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surgical robot system efficacy safety thoracic surgery

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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single-port robot group

Group Type EXPERIMENTAL

Surgical robot system

Intervention Type PROCEDURE

SHURUI Single-port surgical robot system

Interventions

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Surgical robot system

SHURUI Single-port surgical robot system

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 75 years, regardless of gender.
* Patients who require endoscopic surgical treatment and have indications for lung segment/lobe resection; for pre-trial subjects, there is no restriction on the type of procedure, and inclusion is based on the investigator's judgment of having indications for thoracic surgery.
* Preoperative ASA classification of I-III.
* Voluntary participation in the clinical trial and willingness to provide informed.

consent, either by the subject or their guardian.

* Willingness to cooperate and complete trial follow-up and related examinations.

Exclusion Criteria

* Patients with a history of thoracic surgery or previous history of other malignant tumors deemed unsuitable for inclusion by the investigator.
* Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal diseases) or physical weakness who cannot tolerate general anesthesia or surgery.
* Patients with severe bleeding tendencies or coagulation disorders.
* Patients in the active phase of infectious diseases or with other severe non-communicable infections.
* Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis seropositive patients.
* Patients with a suspected or confirmed alcohol, drug, or substance addiction.
* Patients with a history of epilepsy, mental illness, or cognitive impairment.
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
* Participation in other interventional clinical trials within 3 months prior to signing the informed consent form.
* Other situations in which the investigator deems inappropriate for participation in this clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianxing He, M.D.

Role: CONTACT

Phone: +86-20-83337792

Email: [email protected]

Facility Contacts

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Jianxing He, M.D.

Role: primary

Other Identifiers

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EC-2023-087(QX)-03

Identifier Type: -

Identifier Source: org_study_id