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The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

NCT07277088 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

  • Pulmonary Nodules
  • Lung Cancer (Diagnosis)
  • Percutaneous Needle Biopsy
  • Transthoracic Needle Biopsy
  • Robotic Assisted Intervention

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.

Sponsors & Collaborators

  • Shanghai United Imaging Intelligence Co., Ltd

    collaborator UNKNOWN

  • Jiayuan Sun

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-05-30
Completion
2027-05-30

Countries

  • China

Study Locations

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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 NCT07277088 on ClinicalTrials.gov