DeafnessNCT01796236
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
A study testing Minimally invasive surgery and BA400 and Traditional surgery and BA300 in people with Deafness and Hearing Loss, run by Cochlear Bone Anchored Solutions at 7 sites in 4 countries.
Trial summary
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness, Hearing Loss, Hearing Loss, Conductive
- What is being tested?
- Minimally invasive surgery and BA400 and Traditional surgery and BA300
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Eligible for the Baha system
- Signed informed consent
Who cannot join
- Patient scheduled for simultaneously bilateral implant surgery
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow the cleaning instruction
- Unable to follow investigational procedures, e.g. to complete quality of life scales
- Participation in another investigation with pharmaceuticals and/or device
- Condition that may have an impact on the outcome of the investigation as judged by the investigator
- Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Netherlands4 sites
KNO arts, Amphia Ziekenhuis
Breda
Deventer Ziekenhuis
Deventer
Dept. ENT/KNO
Eindhoven, 5623
NT department
Maastricht, 6202
Spain1 site
Otorhinolaryngology, Hospital Clinico Universitario De Valencia
Valencia, ES-46010
About this study
Official title: Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
Read the detailed description
Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact.
The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012.
The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- Being tested
- Minimally invasive surgery and BA400, Traditional surgery and BA300
- Keywords
- Bone anchored hearing aid, Bone anchored implant, Abbreviated Profile of Hearing Aid Benefit (APHAB), Health Utility Index (HUI), Holgers Index, Implant stability
- Medical subject headings
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgery and BA400Device
The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).
Traditional surgery and BA300Device
The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgery and BA400 | Active comparator | This arm involves no soft tissue reduction around the BA400 implant. Receives: Device: Minimally invasive surgery and BA400 |
| Traditional surgery and BA300 | Active comparator | This arm involves traditional soft tissue reduction around the BA300 implant Receives: Device: Traditional surgery and BA300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:
- Holgers Index >=2 any time between 3 weeks to 1 year
- Any overgrowth any time between 3 weeks to 1 year
- Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year
- Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Measured: 12 months
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:
- Holgers Index >=2 any time between 3 weeks to 1 year
- Any overgrowth any time between 3 weeks to 1 year
- Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year
- Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Measured: 36 months
Secondary outcomes (12)
Surgery Time
Surgery time (minutes) was recorded
Measured: Day 0
Wound Healing
A surgeon or a surgical nurse determined if the wound was healed or not healed.
Measured: Day 10, Weeks 3, 6, 12 and 24
Inflammation - Max of Holgers Index
Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.
- No irritation
- Slight redness. Local temporary treatment, if needed
- Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*
- Reddish and moist; sometimes granulations tissue, revision surgery is indicated* R. Removal of the abutment / implant necessary due to infection* R Removal of implant for reasons not related to skin problems*
Measured: From Day 10 to 12 Months, and to 36 Months
Inflammation - Holgers Index by Visit
Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used:
- No irritation. Epidermal debris removed, if present
- Slight redness. Local temporary treatment, if needed
- Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*
- Reddish and moist; sometimes granulations tissue, revision surgery is indicated*
- Removal of the abutment / implant necessary due to infection* R. Removal of implant for reasons not related to skin problems*
Measured: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36
Max Numbness
Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used:
- No numbness
- Numbness within 2 cm from the abutment
- Numbness within and beyond 2 cm from the abutment
Measured: 12 & 36 months
Pain in the Scar and Neuropathic Pain
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.
Measured: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.
Measured: 12 months
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.
Measured: 36 months
Pain by Visit - Categorical
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.
Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'.
Measured: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Soft Tissue Thickening/Overgrowth
The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale:
- No soft tissue thickening or overgrowth
- Slight soft tissue thickening or overgrowth
- Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated*
- Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.*
- Should also be reported on the AE page in the CRF
Measured: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Visible Abutment Length by Visit for Patients With no Change of Abutment
The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant.
In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment
Measured: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36.
The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10.
The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color).
Both patient and observer should also score the overall opinion of the scar on the 1-10 scale.
For all above scales 1=normal skin, 10 worst scar imaginable.
Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable).
The "pain not with in the scar" variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain
Measured: Week 12, Months 12 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear Bone Anchored Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Stokroos, Professor, Principal investigator, NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796236
- Sponsor's protocol ID
- CBAS5439
- Status last verified
- Feb 2019
- First submitted
- 16 Jan 2013
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.
PubMed 32231633
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up
- ClinicalTrials.gov ID
- NCT01796236
- Acronym / sponsor ID
- CBAS5439
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- Keywords
- Bone anchored hearing aid, Bone anchored implant, Abbreviated Profile of Hearing Aid Benefit (APHAB), Health Utility Index (HUI), Holgers Index, Implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cochlear Bone Anchored SolutionsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 22 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
Detailed description
Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact.
The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012.
The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery and BA400 | Active comparator | Device: Minimally invasive surgery and BA400This arm involves no soft tissue reduction around the BA400 implant. |
| Traditional surgery and BA300 | Active comparator | Device: Traditional surgery and BA300This arm involves traditional soft tissue reduction around the BA300 implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for the Baha system
- Signed informed consent
Key exclusion criteria (8 listed)
- Patient scheduled for simultaneously bilateral implant surgery
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow the cleaning instruction
- Unable to follow investigational procedures, e.g. to complete quality of life scales
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 |
|---|---|---|
| Minimally invasive surgery and BA400The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). | Device | Minimally invasive surgery and BA400 |
| Traditional surgery and BA300The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm). | Device | Traditional surgery and BA300 |
Primary outcome
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index >=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Time frame: 36 months
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index >=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
12 secondary outcomes
Surgery Time
Time frame: Day 0
Wound Healing
Time frame: Day 10, Weeks 3, 6, 12 and 24
Inflammation - Max of Holgers Index
Time frame: From Day 10 to 12 Months, and to 36 Months
Inflammation - Holgers Index by Visit
Time frame: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36
Max Numbness
Time frame: 12 & 36 months
Pain in the Scar and Neuropathic Pain
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36
Pain - Maximum of Neuropathic and Scar Pain
Time frame: 12 months
Pain - Maximum of Neuropathic and Scar Pain
Time frame: 36 months
Pain by Visit - Categorical
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Soft Tissue Thickening/Overgrowth
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Visible Abutment Length by Visit for Patients With no Change of Abutment
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36.
Time frame: Week 12, Months 12 and 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32231633van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.
Related trials for Deafness
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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 Stokroos, Professor principal investigator
NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgery and BA400 and Traditional surgery and BA300 in people with Deafness and Hearing Loss, run by Cochlear Bone Anchored Solutions at 7 sites in 4 countries.
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 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: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, France, Spain, Sweden. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability (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?
On the ClinicalTrials.gov record for NCT01796236, which also lists 1 linked publication.
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 26 Feb 2019.