Surgical IncisionNCT02989363
Evaluation of the Use of Resources and Costs
A study testing Device O-Arm in DBS, Device O-Arm in RAQUIS and Not device O-Arm in DBS in people with Surgical Incision, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Device O-Arm in DBS, Device O-Arm in RAQUIS and Not device O-Arm in DBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Dec 2017
- 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
- Patients aged ≥18 years.
- Signed informed consent.
- Patients with indication for DBS surgery for movement disorders, epilepsy and obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels 1,2 and 3 in a degenerative disease
Who cannot join
- Patients who have had pediatric instrumented surgery.
- Patients in which the pedicle screws are inserted for neoplasia or other disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Sanitaria La Fe
Valencia, Valencia, 46026
Elena Garcia, 34961246611, investigacion_clinica@iislafe.es
About this study
Official title: Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries
Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries
Read the detailed description
To measure the use of health resources in application A (with DBS) and in application B (vertebral fusions), in patients in the intervention group with O-arm and in the control group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical, post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))
- Conditions
- Surgical Incision
- Being tested
- Device O-Arm in DBS, Device O-Arm in RAQUIS, Not device O-Arm in DBS, Not device O-Arm in RAQUIS
- Keywords
- deep brain surgery and complex back surgery
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device O-Arm in DBSProcedure or surgery
Deep brain stimulation surgeries with device O-Arm
Device O-Arm in RAQUISProcedure or surgery
Complex back surgeries with the device O-Arm
Not device O-Arm in DBSProcedure or surgery
Deep brain stimulation surgeries without the device O-Arm
Not device O-Arm in RAQUISProcedure or surgery
Complex back surgeries without the device O-Arm
| Study group | Role | What they receive |
|---|---|---|
| O-Arm in deep brain stimulation surgeries (DBS) | Experimental | Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) Receives: Procedure: Device O-Arm in DBS |
| Control group Not O-Arm in deep brain stimulation surgeries | Experimental | Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) Receives: Procedure: Not device O-Arm in DBS |
| O-Arm in complex back surgeries (RAQUIS) | Experimental | Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS) Receives: Procedure: Device O-Arm in RAQUIS |
| Control group Not O-Arm in complex back surgeries (RAQUIS) | Experimental | Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS) Receives: Procedure: Not device O-Arm in RAQUIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
Measured: 12 months
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)
Measured: 6 months
Secondary outcomes (7)
Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery
Measured: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery
Measured: 12 months
Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary
Measured: 12 months
Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery
Measured: 6 months
Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery
Measured: 12 months
Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention
Measured: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention
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 Dec 2016 (estimated)
- Study startOct 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Carlos Botella, Principal investigator, Instituto de Investigación Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989363
- Sponsor's protocol ID
- Study ECOPRES
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries
- ClinicalTrials.gov ID
- NCT02989363
- Acronym / sponsor ID
- Study ECOPRES
- Conditions
- Surgical Incision
- Keywords
- deep brain surgery and complex back surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Dec 2016 (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.
Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries
Detailed description
To measure the use of health resources in application A (with DBS) and in application B (vertebral fusions), in patients in the intervention group with O-arm and in the control group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical, post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| O-Arm in deep brain stimulation surgeries (DBS) | Experimental | Procedure: Device O-Arm in DBSUse of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) |
| Control group Not O-Arm in deep brain stimulation surgeries | Experimental | Procedure: Not device O-Arm in DBSNot use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) |
| O-Arm in complex back surgeries (RAQUIS) | Experimental | Procedure: Device O-Arm in RAQUISUse of image surgery with technology O-Arm in complex back surgeries (RAQUIS) |
| Control group Not O-Arm in complex back surgeries (RAQUIS) | Experimental | Procedure: Not device O-Arm in RAQUISNot use of image surgery with technology O-Arm in complex back surgeries (RAQUIS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥18 years.
- Signed informed consent.
- Patients with indication for DBS surgery for movement disorders, epilepsy and obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels 1,2 and 3 in a degenerative disease
Key exclusion criteria (2 listed)
- Patients who have had pediatric instrumented surgery.
- Patients in which the pedicle screws are inserted for neoplasia or other disease.
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 |
|---|---|---|
| Device O-Arm in DBSDeep brain stimulation surgeries with device O-Arm | Procedure or surgery | O-Arm in deep brain stimulation surgeries (DBS) |
| Device O-Arm in RAQUISComplex back surgeries with the device O-Arm | Procedure or surgery | O-Arm in complex back surgeries (RAQUIS) |
| Not device O-Arm in DBSDeep brain stimulation surgeries without the device O-Arm | Procedure or surgery | Control group Not O-Arm in deep brain stimulation surgeries |
| Not device O-Arm in RAQUISComplex back surgeries without the device O-Arm | Procedure or surgery | Control group Not O-Arm in complex back surgeries (RAQUIS) |
Primary outcome
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
Time frame: 12 months
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)
Time frame: 6 months
7 secondary outcomes
Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery
Time frame: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery
Time frame: 12 months
Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary
Time frame: 12 months
Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery
Time frame: 6 months
Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery
Time frame: 12 months
Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention
Time frame: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Botella principal investigator
Instituto de Investigación Sanitaria La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device O-Arm in DBS, Device O-Arm in RAQUIS and Not device O-Arm in DBS in people with Surgical Incision, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Garcia (0034961246711, investigacion_clinica@iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups) (time frame: 12 months). The study lists 2 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 12 Dec 2016.