Adult Spinal Cord NeoplasmNCT01345903
Robotic-Assisted Surgery in Treating Patients With Spine Tumors
A study testing therapeutic conventional surgery in people with Adult Spinal Cord Neoplasm and Spinal Bone Metastases, run by City of Hope Medical Center.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases
- What is being tested?
- therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
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
Read the detailed description
PRIMARY OBJECTIVES:
- To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.
SECONDARY OBJECTIVES:
- To compare complication rates, operative time and estimated blood loss with historical controls.
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.
II. Routine imaging of the spinal segment.
OUTLINE:
Patients undergo robotic-assisted surgery using the da Vinci robot.
After completion of study treatment, patients are followed up for 100 days.
- Being tested
- therapeutic conventional surgery
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
Undergo robotic-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (surgery) | Experimental | Patients undergo robotic-assisted surgery using the da Vinci robot Receives: Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates with 95% confidence bounds of +/- 31% or smaller
Measured: For 100 days post-surgery
Estimated blood loss
Measured: For 100 days post-surgery
Operation duration
Measured: At the completion of surgery
Complication rate
Measured: For 100 days post-surgery
Demographic and clinical data such as stage, grade and histology
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startDec 2012
- Primary completionJun 2013 (estimated)
Why it stopped: The protocol needs to be re-designed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal Cord NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mike Chen, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345903
- Sponsor's protocol ID
- 09202
- Other IDs
- NCI-2011-00691
- Status last verified
- Nov 2012
- First submitted
- 28 Apr 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
- ClinicalTrials.gov ID
- NCT01345903
- Acronym / sponsor ID
- 09202
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The protocol needs to be re-designed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 2 May 2011 (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 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
Detailed description
PRIMARY OBJECTIVES:
- To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.
SECONDARY OBJECTIVES:
- To compare complication rates, operative time and estimated blood loss with historical controls.
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.
II. Routine imaging of the spinal segment.
OUTLINE:
Patients undergo robotic-assisted surgery using the da Vinci robot.
After completion of study treatment, patients are followed up for 100 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (surgery) | Experimental | Procedure: therapeutic conventional surgeryPatients undergo robotic-assisted surgery using the da Vinci robot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| therapeutic conventional surgeryUndergo robotic-assisted surgery | Procedure or surgery | Treatment (surgery) |
Primary outcome
Complication rates with 95% confidence bounds of +/- 31% or smaller
Time frame: For 100 days post-surgery
Estimated blood loss
Time frame: For 100 days post-surgery
Operation duration
Time frame: At the completion of surgery
Complication rate
Time frame: For 100 days post-surgery
Demographic and clinical data such as stage, grade and histology
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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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.
Mike Chen, MD, PhD principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic conventional surgery in people with Adult Spinal Cord Neoplasm and Spinal Bone Metastases, run by City of Hope Medical Center.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Complication rates with 95% confidence bounds of +/- 31% or smaller (time frame: For 100 days post-surgery). The study lists 5 primary outcomes in all. 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 Nov 2012.