Clinical trial · Interventional
Evaluating the Pre-Positioning Frame for Robotic Acoustic Neuroma Removal Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants have been enrolled. The PI Is leaving the institution and we wish to close the study at this time.
Summary
Brief summary (as posted)
Otologic surgery often involves a mastoidectomy to safely access the inner ear. In this procedure, a portion of the mastoid part of the temporal bone is removed. The surgery is lengthy and challenging because many critical structures are embedded in the mastoid and are difficult to identify and accurately remove with a surgical drill. In previous work, the investigators developed a compact, bone-attached robot to automate mastoidectomy drilling for translabyrinthine acoustic neuroma removal (TANR). The robot does not attach directly to the bone. Instead, a rigid surgical fixture which the investigators call a prepositioning frame (PPF) is attached to the temporal bone, and the robot attaches to the PPF. Attaching the robot to the participant eliminates the need for an expensive image guidance system to compensate for participant motion, but requires a compact robot with a limited range of motion. The PPF supports the robot on the head such that a planned mastoidectomy volume is within the robot's range of motion. In this study, the investigators plan to test the PPF by attaching it to ten participants. By processing an intraoperative CT scan of the attached PPF, the investigators will measure the percentage of each planned mastoidectomy that would be reachable if the robot were attached. The investigators will also measure the time required to attach the PPF. The data the investigators acquire will enable further improvements to the PPF design, which would be advantageous before proceeding to robotic drilling experiments.
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 |
|---|---|---|---|
| Acoustic Neuroma | Vestibular Schwannoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testing of Pre-Positioning Frame | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Testing of Pre-Positioning Frame
- description
- Placement of bone screws, CT scanning, Surgical planning, Robot motion planning
- interventionNames
- Other: Testing of Pre-Positioning Frame
Primary outcomes (2)
- measure
- Time in minutes required to attach the PPF.
- timeFrame
- From PPF anchored to temporal bone until bone screws are loosened and PPF removed, estimated 15-30 minutes.
- measure
- Percentage of planned mastoidectomy reachable by robot
- timeFrame
- During the use of the PPF, estimated 15-30 minutes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 21-80 years old undergoing TANR who consent to participation. * Preop Head CT scan as part of routine care. * Skull thickness a minimum of 3.75mm in planned attachment areas. Exclusion Criteria: * Pregnant women. As per standard of care in preparation for surgery, all females of childbearing age will undergo a pregnancy test during the medical evaluation for surgery. * Patients with severe comorbidities, such as chronic otitis media, history of stroke, brain trauma, or hydrocephalus. * Patients with a history of allergic reactions to lidocaine. * Patients with severe anatomical abnormality of the temporal bone. * Patients with history of allergic reaction to titanium, because the bone screws used in this study are made of a titanium alloy. * Patients who are at unacceptable risk for general anesthesia. * Patients who are at unacceptable risk for the intraoperative CT scan(s). * Patients who are unable to give informed consent.
References
Publications (0)
Data not yet available