Clinical trial · Observational
Accuracy and Safety of Coplanar Template Assistance for Head and Neck Biopsies.
A Prospective Single-arm Cohort Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Neck and Head Biopsies.
NCT05396183CI-TRIAL-00058782unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 is a prospective single-arm cohort study to evaluate the accuracy and safety of three-dimensional printing co-planer template(3D-PCT) for computed tomography (CT)-guided neck and head biopsy .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 3D-PCT group
- description
- Participant will receive three-dimensional printing co-planar template (3D-PCT) assisted CT-guided head and neck neoplasm biopsy and prospective accuracy and safety data will record.
Primary outcomes (1)
- measure
- Accuracy
- timeFrame
- During the operation.
- description
- Depth and Angle difference between actual puncture and planned puncture pathway.
Secondary outcomes (2)
- measure
- Complication rate
- timeFrame
- During the first month after operation.
- description
- Adverse event include needle track implantation metastasis and operation-related complications (e.g. bleeding, nerve injury, air embolism).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: (1) Ages 18 to 80; (2) KPS\>70 points, an estimated life expectancy of greater than 3 months; (3)Head and neck masses or nodules can be revealed by CT scan, MRI or ultrasonic examination; (4) Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week) ; (5) No serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture; (6) Planned biopsy with applicable puncture path; (7) With informed consent. Exclusion Criteria: (1)Biopsy needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding; (2)Poor organ function (e.g. poorly controlled high blood pressure); (3) Any contraindication of percutaneous head and neck biopsy; (4) Poor compliance, unable to complete coordination; (5) Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.