Skull BaseNCT01705821
Forces During Skull Base Surgery
An observational study of Skull Base and Pituitary, run by Vanderbilt University at 1 site in United States.
Trial summary
This study is designed to measure forces applied using standard surgical instruments at the skull base during resection of skull base lesions. This data will be useful for optimizing an active canula robot for assisting in skull base surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skull Base, Pituitary, Robotics
- What is being tested?
- Use of force sensing surgical curette and Removal of pituitary tumor using modified curette
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergoing standard endonasal skull base surgery.
Who may be able to join
- Any male or female patient 18-75 years old undergoing endonasal skull base surgery for a skull base lesion.
- Competent in decision making process and able to sign a written informed consent form.
Who cannot join
- -Any patient not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Skull Base Center
Nashville, Tennessee, 37212
About this study
Official title: Measuring Forces Applied During Skull Base Surgery
This study is designed to measure forces applied using standard surgical instruments at the skull base during resection of skull base lesions. This data will be useful for optimizing an active canula robot for assisting in skull base surgery. We hypothesize that through measurement of forces generated during routine endoscopic skull base surgery we will be able to optimize the canulas of an active canula robot for skull base surgery.
Read the detailed description
At some time in their lives, 1 in 5 people will have a pituitary tumor, and 1 in 600 of these will have the tumor grow large enough (>1 cm in diameter) that surgical resection is required. Traditionally, surgery to remove pituitary tumors or other tumors at the skull base requires transcranial or transfacial access. In these approaches, large traumatic, often disfiguring, openings must be created in the patient's forehead or cheek. Endonasal skull base surgery reduces invasiveness resulting in less trauma, fewer complications, and shorter surgical time. However, despite the compelling advantages for the patient, only a small percentage of skull base surgeries are done endonasally. While exact statistics are not available, the current best estimate in the literature is that less than 50% and most likely less than 20% of these tumors are addressed by endonasal surgery.
The endonasal approach is underemployed despite its demonstrated benefits to the patient because existing surgical instruments have limited dexterity and approach angles, and simultaneously manipulating several of them through a nostril while performing complex surgical procedures is so technically challenging that only a small number of expert surgeons can accomplish it. Even for these experts, mortality rates are non-negligible (0.9%), and there remain contraindications to the endonasal approach, including occlusion of the surgical site by delicate and critical neurovascular structures (e.g. carotid arteries, optic nerves), inability to fully reconstruct the dura due to lack of surgical tool dexterity, and long surgical duration. All of these contraindications are directly related to limitations in instrument dexterity and visualization, which motivates the development of a robotic system for endonasal skull base surgery. Such a robot can potentially increase surgical dexterity and reduce the technical complexity of the procedure for surgeons, thereby increasing the percentage of patient who benefit from the endonasal technique.
While many robotic systems have been developed for intravascular interventions as well as natural orifice surgery though other orifices, comparatively few systems have been targeted at endonasal surgery. This is likely due to the smaller size of the nasal cavity and nostril compared to other natural orifices.
For endonasal robots, the limited space available in the nostril opening, combined with the need to work dexterously within the cavities in the head, implies that instrument shafts must be small in diameter while enabling dexterous motions of instrument tips. A recently invented robot design that matches these characteristics is the concentric tube robot concept, which is also known as by the name active cannula.
A robot suitable for endonasal surgery is being developed (see reference #3), however in order to optimize this robotic system, intraoperative data must be obtained to determine how the robot interacts with the patient's tissues. The aim of this study is to modify a traditional tool used in the operating room to allow determination of forces at the skull base on both hard and soft tissues. This surgical curette will be used in the standard fashion during endonasal skull base surgery, however will provide valuable information.
The modified curette will consist of two segments joined by a Nano17 6-axis force sensor. (Image 1) The force sensor is integrated into the shaft of the instrument (a standard neurosurgical ring curette) and insulated from the shaft with two polyetherimide (also known as ULTEM) disks so that no current can be transmitted from the force sensor to the curette. The sensor is held to the shaft by medical grade adhesive and set screws.
The patients will be recruited from the PIs clinical practice. Informed consent will be obtained. At the appropriate time during surgery this curette will be used to collect force date. This force transducer operates at 5V (4.8-9V range). These transducers are commonly used in medical and dental research (see reference #5).
No additional operating room or anesthesia time will be required.
- Conditions
- Skull Base, Pituitary, Robotics, Endonasal Surgery, Sinus Surgery
- Being tested
- Use of force sensing surgical curette, Removal of pituitary tumor using modified curette
- Keywords
- Skull base, Pituitary, Robotics, Endonasal surgery, Sinus surgery
- Medical subject headings
- Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of force sensing surgical curetteDevice
Use of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery.
Removal of pituitary tumor using modified curetteProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Skull Base Surgery Candidate | Patient with a skull base lesion will undergo use of standard surgical curette with force sensor built into shaft. 6-axis force and torque data will be collected during the surgical procedure. Receives: Device: Use of force sensing surgical curette; Procedure: Removal of pituitary tumor using modified curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-axis force and torque data from routine endoscopic transnasal skull base surgery
This data will be collected and recorded via a computer interface with our sensorized tool and recorded in standard units for force and torque. We will also look at the variability of forces between patients after collecting this data. The data will be useful in optimizing a robotic system for endonasal surgery as described in the secondary outcome measure.
Measured: 12 months
Secondary outcomes (1)
Percent tumor removal in skull and cadaver studies
The force and torque data will allow our team of Engineers to optimize our robotic system to be best suited for removing pituitary tumors transnasally. The robot consists of specially designed flexible arms with end effectors that each need to be able to withstand and produce the necessary forces to complete pituitary tumor excision. This will be measured by optimizing our robot based on the findings in the primary outcome measure and then evaluating the robot for efficiency and effectiveness of mock pituitary tumor removal from skull and cadaver specimens. We will investigate percent tumor removal and speed of tumor removal once the robot is optimized.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull BaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Webster, Vanderbilt University
- Investigators
- Robert Webster, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705821
- Sponsor's protocol ID
- 121194
- Status last verified
- Dec 2014
- First submitted
- 8 Oct 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Forces Applied During Skull Base Surgery
- ClinicalTrials.gov ID
- NCT01705821
- Acronym / sponsor ID
- 121194
- Conditions
- Skull Base, Pituitary, Robotics, Endonasal Surgery, Sinus Surgery
- Keywords
- Skull base, Pituitary, Robotics, Endonasal surgery, Sinus surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to measure forces applied using standard surgical instruments at the skull base during resection of skull base lesions. This data will be useful for optimizing an active canula robot for assisting in skull base surgery. We hypothesize that through measurement of forces generated during routine endoscopic skull base surgery we will be able to optimize the canulas of an active canula robot for skull base surgery.
Detailed description
At some time in their lives, 1 in 5 people will have a pituitary tumor, and 1 in 600 of these will have the tumor grow large enough (>1 cm in diameter) that surgical resection is required. Traditionally, surgery to remove pituitary tumors or other tumors at the skull base requires transcranial or transfacial access. In these approaches, large traumatic, often disfiguring, openings must be created in the patient's forehead or cheek. Endonasal skull base surgery reduces invasiveness resulting in less trauma, fewer complications, and shorter surgical time. However, despite the compelling advantages for the patient, only a small percentage of skull base surgeries are done endonasally. While exact statistics are not available, the current best estimate in the literature is that less than 50% and most likely less than 20% of these tumors are addressed by endonasal surgery.
The endonasal approach is underemployed despite its demonstrated benefits to the patient because existing surgical instruments have limited dexterity and approach angles, and simultaneously manipulating several of them through a nostril while performing complex surgical procedures is so technically challenging that only a small number of expert surgeons can accomplish it. Even for these experts, mortality rates are non-negligible (0.9%), and there remain contraindications to the endonasal approach, including occlusion of the surgical site by delicate and critical neurovascular structures (e.g. carotid arteries, optic nerves), inability to fully reconstruct the dura due to lack of surgical tool dexterity, and long surgical duration. All of these contraindications are directly related to limitations in instrument dexterity and visualization, which motivates the development of a robotic system for endonasal skull base surgery. Such a robot can potentially increase surgical dexterity and reduce the technical complexity of the procedure for surgeons, thereby increasing the percentage of patient who benefit from the endonasal technique.
While many robotic systems have been developed for intravascular interventions as well as natural orifice surgery though other orifices, comparatively few systems have been targeted at endonasal surgery. This is likely due to the smaller size of the nasal cavity and nostril compared to other natural orifices.
For endonasal robots, the limited space available in the nostril opening, combined with the need to work dexterously within the cavities in the head, implies that instrument shafts must be small in diameter while enabling dexterous motions of instrument tips. A recently invented robot design that matches these characteristics is the concentric tube robot concept, which is also known as by the name active cannula.
A robot suitable for endonasal surgery is being developed (see reference #3), however in order to optimize this robotic system, intraoperative data must be obtained to determine how the robot interacts with the patient's tissues. The aim of this study is to modify a traditional tool used in the operating room to allow determination of forces at the skull base on both hard and soft tissues. This surgical curette will be used in the standard fashion during endonasal skull base surgery, however will provide valuable information.
The modified curette will consist of two segments joined by a Nano17 6-axis force sensor. (Image 1) The force sensor is integrated into the shaft of the instrument (a standard neurosurgical ring curette) and insulated from the shaft with two polyetherimide (also known as ULTEM) disks so that no current can be transmitted from the force sensor to the curette. The sensor is held to the shaft by medical grade adhesive and set screws.
The patients will be recruited from the PIs clinical practice. Informed consent will be obtained. At the appropriate time during surgery this curette will be used to collect force date. This force transducer operates at 5V (4.8-9V range). These transducers are commonly used in medical and dental research (see reference #5).
No additional operating room or anesthesia time will be required.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skull Base Surgery Candidate | – | Device: Use of force sensing surgical curette, Procedure: Removal of pituitary tumor using modified curettePatient with a skull base lesion will undergo use of standard surgical curette with force sensor built into shaft. 6-axis force and torque data will be collected during the surgical procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing standard endonasal skull base surgery.
Key inclusion criteria (2 listed)
- Any male or female patient 18-75 years old undergoing endonasal skull base surgery for a skull base lesion.
- Competent in decision making process and able to sign a written informed consent form.
Key exclusion criteria (1 listed)
- -Any patient not able to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of force sensing surgical curetteUse of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery. | Device | Skull Base Surgery Candidate |
| Removal of pituitary tumor using modified curette | Procedure or surgery | Skull Base Surgery Candidate |
Primary outcome
6-axis force and torque data from routine endoscopic transnasal skull base surgery
Time frame: 12 months
This data will be collected and recorded via a computer interface with our sensorized tool and recorded in standard units for force and torque. We will also look at the variability of forces between patients after collecting this data. The data will be useful in optimizing a robotic system for endonasal surgery as described in the secondary outcome measure.
1 secondary outcome
Percent tumor removal in skull and cadaver studies
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Webster, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Base and Pituitary, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-axis force and torque data from routine endoscopic transnasal skull base surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.