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NOT YET RECRUITING
NCT07277088
NA

The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

Sponsor: Jiayuan Sun

View on ClinicalTrials.gov

Summary

This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.

Official title: A Prospective, Single-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of the Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2025-12-10

Completion Date

2027-05-30

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Percutaneous Needle Biopsy with Interventional Surgical Control System

Patients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.

DIAGNOSTIC_TEST

Conventional Manual Percutaneous Needle Biopsy

Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.

Locations (1)

Shanghai Chest Hospital

Shanghai, China