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Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures

NCT06581107 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-03

No results posted yet for this study

Summary

This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance.

The main questions this study aims to answer are:

1. Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas;
2. Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment;
3. Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time;
4. Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate;
5. Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.

Conditions

Interventions

PROCEDURE

CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation

During the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).

Sponsors & Collaborators

  • Wuhan United Imaging Surgical co., ltd.

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Wenge Xing, Professor · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581107 on ClinicalTrials.gov