Clinical trial · Interventional
Robotic-Assisted Surgery in Treating Patients With Spine Tumors
A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
NCT01345903CI-TRIAL-00008466withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The protocol needs to be re-designed.
Summary
Brief summary (as posted)
This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Spinal Cord Neoplasm | Adult Spinal Cord Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Bone Metastases | — | UNRESOLVED | — |
| Spinal Cord Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgery)
- description
- Patients undergo robotic-assisted surgery using the da Vinci robot
- interventionNames
- Procedure: therapeutic conventional surgery
Primary outcomes (5)
- measure
- Complication rates with 95% confidence bounds of +/- 31% or smaller
- timeFrame
- For 100 days post-surgery
- measure
- Estimated blood loss
- timeFrame
- For 100 days post-surgery
- measure
- Operation duration
- timeFrame
- At the completion of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI) * Karnofsky performance status (PS) of \>= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1 * Expected survival greater than 3 months * Patient must be able to understand and sign a study-specific informed consent form Exclusion Criteria: * Previous surgery at that specific segment * Radiation at that specific spinal segment within the last 2 months * Karnofsky PS \< 80 or ECOG PS \> 1 * Pregnancy (due to risk of anesthesia) * The presence of medical conditions which contraindicate general anesthesia * Unexplained fever or untreated, active infection * Inability to obtain exposure to allow performance of the planned spine surgical procedure * History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.