Trials / Not Yet Recruiting
Not Yet RecruitingNCT07277088
The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- Sponsor
- Jiayuan Sun · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-10
- Primary completion
- 2027-05-30
- Completion
- 2027-05-30
- First posted
- 2025-12-11
- Last updated
- 2025-12-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07277088. Inclusion in this directory is not an endorsement.