ScoliosisASTSNCT03330158
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
A study testing ASTS in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- ASTS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2019to 31 Dec 2025
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient 4 to 10 years
- Patient weight between 15kg at 50kg
- Introducing severe scoliosis (Cobb angle> 40 °) with early onset
- Failed or cons-indication of conservative treatment (cast or brace)
- Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement).
Who cannot join
- Contraindication to surgery
- Age less than 4 years or above 10 years
- Weight less 15kg and above 50 kg
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.
The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
Read the detailed description
Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function.
The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation.
Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity.
Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications.
Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
- Conditions
- Scoliosis
- Being tested
- ASTS
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTSDevice
Implantation of a motorized spinal distraction rod
| Study group | Role | What they receive |
|---|---|---|
| ASTS device | Experimental | Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10 Receives: Device: ASTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Implant the device
The surgeon will have to say if the implantation of the device has been done or not
Measured: Day 0: the day of the implantation
Change of the position of the implant
1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still well positioning
Measured: 1 years after the implantation
Change of the position of the implant
2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
Measured: 2 years after the implantation
Change of the position of the implant
3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
Measured: 3 years after the implantation
Change of the implant's length
The elongation of the implant will be measured in mm on the digital radiography
Measured: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
Secondary outcomes (26)
Post-surgical pain
Self-assessment of pain using a visual analog scale
Measured: 3 months, after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Measured: months after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Measured: 9 months after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Measured: 1 year after the implantation
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Measured: Day 0
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Measured: 6 months after the implantation
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Measured: 1 year after the implantation
to ease for the surgeon to implant the device,
Number of participant with ease for the surgeon to implant the device,
Measured: Day 0
wound closure without tension,
Number of participant with closure of the wound without tension,
Measured: Day 0
good positioning of the radiographic implant.
Number participant with good positioning of the radiographic implant.
Measured: Day 0
Number of medical visits
Measure of the number of medical visit in the year after implant
Measured: 1 year
Determine the number of iterative extensions made during follow-up
Number of iterative extensions of 1 year.
Measured: 1 year
correction of deformation immediately after the operation,
Number of participant with correction of deformation immediately after the operation,
Measured: 3 months, 6 months, 9 month and 1 year
correction of deformation immediately after the operation,
Number of participant with correction of deformation immediately after the operation,
Measured: 3 months after implantation
Loss correction at 1 year
Loss correction at 1 year
Measured: 6 months after implantation
Loss correction at 1 year
Loss correction at 1 year
Measured: 9 month after implantation
Loss correction at 1 year
Loss correction at 1 year
Measured: 1 year after implantation
Increase the distance T1-S1 at 1 year
Increase the distance T1-S1 at 1 year (in mm)
Measured: 1 year
Effective Elongation measured on radiographs of specification of the device (in mm)
Effective Elongation measured on radiographs of specification of the device (in mm)
Measured: 3 months after implantation
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Measured: 6 months after implantation
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Measured: 9 month after implantation
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Measured: 1 year after implantation
Nature of complications
describe the nature of complication
Measured: 1 years
Nature of complications
describe the nature of complication
Measured: 2 years
Nature of complications
describe the nature of complication
Measured: 3 years
Nature of complications
describe the nature of complication
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start5 Feb 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Accadbled, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330158
- Sponsor's protocol ID
- RC31/15/7851
- Acronym
- ASTS
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2016
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noordeen HM, Shah SA, Elsebaie HB, Garrido E, Farooq N, Al-Mukhtar M. In vivo distraction force and length measurements of growing rods: which factors influence the ability to lengthen? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2299-303. doi: 10.1097/BRS.0b013e31821b8e16.
PubMed 21494191Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2.
PubMed 14616041Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S46-57. doi: 10.1097/01.brs.0000175190.08134.73.
PubMed 16138066Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.
PubMed 20889912Lucas G, Bollini G, Jouve JL, de Gauzy JS, Accadbled F, Lascombes P, Journeau P, Karger C, Mallet JF, Neagoe P, Cottalorda J, De Billy B, Langlais J, Herbaux B, Fron D, Violas P. Complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib: the French experience. Spine (Phila Pa 1976). 2013 Dec 1;38(25):E1589-99. doi: 10.1097/BRS.0000000000000014.
PubMed 24048087Krieg AH, Speth BM, Foster BK. Leg lengthening with a motorized nail in adolescents : an alternative to external fixators? Clin Orthop Relat Res. 2008 Jan;466(1):189-97. doi: 10.1007/s11999-007-0040-3. Epub 2008 Jan 3.
PubMed 18196392Baumgart R. The reverse planning method for lengthening of the lower limb using a straight intramedullary nail with or without deformity correction. A new method. Oper Orthop Traumatol. 2009 Jun;21(2):221-33. doi: 10.1007/s00064-009-1709-4.
PubMed 19685230den Uil CA, Bezemer R, Miranda DR, Ince C, Lagrand WK, Hartman M, Bogers AJ, Spronk PE, Simoons ML. Intra-operative assessment of human pulmonary alveoli in vivo using Sidestream Dark Field imaging: a feasibility study. Med Sci Monit. 2009 Oct;15(10):MT137-141.
PubMed 19789519Kanter KR, Haggerty CM, Restrepo M, de Zelicourt DA, Rossignac J, Parks WJ, Yoganathan AP. Preliminary clinical experience with a bifurcated Y-graft Fontan procedure--a feasibility study. J Thorac Cardiovasc Surg. 2012 Aug;144(2):383-9. doi: 10.1016/j.jtcvs.2012.05.015. Epub 2012 Jun 13.
PubMed 22698555Kerimaa P, Ojala R, Sinikumpu JJ, Hyvonen P, Korhonen J, Markkanen P, Tervonen O, Sequeiros RB. MRI-guided percutaneous retrograde drilling of osteochondritis dissecans of the talus: a feasibility study. Eur Radiol. 2014 Jul;24(7):1572-6. doi: 10.1007/s00330-014-3161-6. Epub 2014 Apr 17.
PubMed 24740345Flynn JM, Emans JB, Smith JT, Betz RR, Deeney VF, Patel NM, Campbell RM. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study. J Pediatr Orthop. 2013 Oct-Nov;33(7):679-84. doi: 10.1097/BPO.0b013e31829d55a2.
PubMed 23812154
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
- ClinicalTrials.gov ID
- NCT03330158
- Acronym / sponsor ID
- ASTS / RC31/15/7851
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.
The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
Detailed description
Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function.
The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation.
Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity.
Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications.
Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASTS device | Experimental | Device: ASTSImplantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient 4 to 10 years
- Patient weight between 15kg at 50kg
- Introducing severe scoliosis (Cobb angle> 40 °) with early onset
- Failed or cons-indication of conservative treatment (cast or brace)
- Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement).
Key exclusion criteria (3 listed)
- Contraindication to surgery
- Age less than 4 years or above 10 years
- Weight less 15kg and above 50 kg
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 |
|---|---|---|
| ASTSImplantation of a motorized spinal distraction rod | Device | ASTS device |
Primary outcome
Ability to Implant the device
Time frame: Day 0: the day of the implantation
The surgeon will have to say if the implantation of the device has been done or not
Change of the position of the implant
Time frame: 1 years after the implantation
1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still well positioning
Change of the position of the implant
Time frame: 2 years after the implantation
2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
Change of the position of the implant
Time frame: 3 years after the implantation
3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
Change of the implant's length
Time frame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
The elongation of the implant will be measured in mm on the digital radiography
26 secondary outcomes
Post-surgical pain
Time frame: 3 months, after the implantation
Post-surgical pain
Time frame: months after the implantation
Post-surgical pain
Time frame: 9 months after the implantation
Post-surgical pain
Time frame: 1 year after the implantation
Survey to evaluate the quality of life
Time frame: Day 0
Survey to evaluate the quality of life
Time frame: 6 months after the implantation
Survey to evaluate the quality of life
Time frame: 1 year after the implantation
to ease for the surgeon to implant the device,
Time frame: Day 0
wound closure without tension,
Time frame: Day 0
good positioning of the radiographic implant.
Time frame: Day 0
Number of medical visits
Time frame: 1 year
Determine the number of iterative extensions made during follow-up
Time frame: 1 year
correction of deformation immediately after the operation,
Time frame: 3 months, 6 months, 9 month and 1 year
correction of deformation immediately after the operation,
Time frame: 3 months after implantation
Loss correction at 1 year
Time frame: 6 months after implantation
Loss correction at 1 year
Time frame: 9 month after implantation
Loss correction at 1 year
Time frame: 1 year after implantation
Increase the distance T1-S1 at 1 year
Time frame: 1 year
Effective Elongation measured on radiographs of specification of the device (in mm)
Time frame: 3 months after implantation
Effective Elongation measured on radiographs of specification of the device
Time frame: 6 months after implantation
Effective Elongation measured on radiographs of specification of the device
Time frame: 9 month after implantation
Effective Elongation measured on radiographs of specification of the device
Time frame: 1 year after implantation
Nature of complications
Time frame: 1 years
Nature of complications
Time frame: 2 years
Nature of complications
Time frame: 3 years
Nature of complications
Time frame: 5 years
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 31 Aug 2026.
- Background: PubMed 21494191Noordeen HM, Shah SA, Elsebaie HB, Garrido E, Farooq N, Al-Mukhtar M. In vivo distraction force and length measurements of growing rods: which factors influence the ability to lengthen? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2299-303. doi: 10.1097/BRS.0b013e31821b8e16.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 14616041Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2.
- Background: PubMed 16138066Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S46-57. doi: 10.1097/01.brs.0000175190.08134.73.
- Background: PubMed 20889912Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.
- Background: PubMed 24048087Lucas G, Bollini G, Jouve JL, de Gauzy JS, Accadbled F, Lascombes P, Journeau P, Karger C, Mallet JF, Neagoe P, Cottalorda J, De Billy B, Langlais J, Herbaux B, Fron D, Violas P. Complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib: the French experience. Spine (Phila Pa 1976). 2013 Dec 1;38(25):E1589-99. doi: 10.1097/BRS.0000000000000014.
- Background: PubMed 18196392Krieg AH, Speth BM, Foster BK. Leg lengthening with a motorized nail in adolescents : an alternative to external fixators? Clin Orthop Relat Res. 2008 Jan;466(1):189-97. doi: 10.1007/s11999-007-0040-3. Epub 2008 Jan 3.
- Background: PubMed 19685230Baumgart R. The reverse planning method for lengthening of the lower limb using a straight intramedullary nail with or without deformity correction. A new method. Oper Orthop Traumatol. 2009 Jun;21(2):221-33. doi: 10.1007/s00064-009-1709-4.
- Background: PubMed 19789519den Uil CA, Bezemer R, Miranda DR, Ince C, Lagrand WK, Hartman M, Bogers AJ, Spronk PE, Simoons ML. Intra-operative assessment of human pulmonary alveoli in vivo using Sidestream Dark Field imaging: a feasibility study. Med Sci Monit. 2009 Oct;15(10):MT137-141.
- Background: PubMed 22698555Kanter KR, Haggerty CM, Restrepo M, de Zelicourt DA, Rossignac J, Parks WJ, Yoganathan AP. Preliminary clinical experience with a bifurcated Y-graft Fontan procedure--a feasibility study. J Thorac Cardiovasc Surg. 2012 Aug;144(2):383-9. doi: 10.1016/j.jtcvs.2012.05.015. Epub 2012 Jun 13.
- Background: PubMed 24740345Kerimaa P, Ojala R, Sinikumpu JJ, Hyvonen P, Korhonen J, Markkanen P, Tervonen O, Sequeiros RB. MRI-guided percutaneous retrograde drilling of osteochondritis dissecans of the talus: a feasibility study. Eur Radiol. 2014 Jul;24(7):1572-6. doi: 10.1007/s00330-014-3161-6. Epub 2014 Apr 17.
- Background: PubMed 23812154Flynn JM, Emans JB, Smith JT, Betz RR, Deeney VF, Patel NM, Campbell RM. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study. J Pediatr Orthop. 2013 Oct-Nov;33(7):679-84. doi: 10.1097/BPO.0b013e31829d55a2.
- Individual participant dataSharing planned: No
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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.
Franck Accadbled, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASTS in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
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 5 inclusion and 3 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 31 Aug 2026. 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 France. 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?
Ability to Implant the device (time frame: Day 0: the day of the implantation). 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?
On the ClinicalTrials.gov record for NCT03330158, which also lists 12 linked publications.
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 31 Aug 2026.