Clinical trial · Interventional
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure.
Validate the Feasibility and Safety of the Robot System by Comparing the CT-fluoroscopy Guidance Versus CT-guided Freehand Needle Biopsy in Participants With Suspected Thoracic or Abdominal Lesions in a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance. The main questions it aims to answer are: 1. Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure. 2. Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment 3. Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate 4. Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion. All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group. Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance. Participants in the control group will receive a freehand needle biopsy under the CT guidance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions | Procedure | — | UNRESOLVED |
| Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group
- description
- Remote controlled, CT-fluoroscopy guided, robot-assisted biopsy procedure of thoracic and abdominal lesions
- interventionNames
- Procedure: CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions
- type
- ACTIVE_COMPARATOR
- label
- Freehand needle biopsy group under the CT guidance
- description
- Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
- interventionNames
- Procedure: Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
Primary outcomes (1)
- measure
- One-time puncture success rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants have suspected thoracic or abdomen lesions. * Participants need to receive CT-guided non-vascular percutaneous biopsy procedure * Lesion size ≥ 10 mm that confirmed by radiologists through the preoperative CT. Exclusion Criteria: * Participants with uncorrectable coagulopathy, infectious lesions in the planned needle trajectory path, pulmonary echinococcosis considered on CT imaging, patients who need mechanical ventilation, hepatic alveolar echinococcosis, coma or other diseases that the investigators think not suitable for joining the study.
References
Publications (0)
Data not yet available