Pectus Excavatum3MPNCT01327274
Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum
A study testing Magnetic Mini-Mover Procedure (Magnimplant) in people with Pectus Excavatum, run by Michael Harrison at 3 sites in United States.
Trial summary
This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Magnetic Mini-Mover Procedure (Magnimplant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to May 2018
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Otherwise healthy male or female with pectus excavatum deformity
- Between 8 and 14 years of age (inclusive)
- Pectus Severity Index > 3.5 (normal 2.56). NOTE: A pectus severity index of 3.5 or greater qualifies as a moderate-to-severe deformity, and justifies operative intervention
- Ability to read, speak and understand English
- Onset of rapid growth of puberty documented by hand/wrist x-ray in early to mid-puberty (defined as bone age in females of 7-13 years, and males of 9-14 years)
Who cannot join
- Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum
- Bleeding disorders
- Heart disease (including arrhythmia)
- Persons with active implantable medical devices (AIMD) such as pacemakers
- Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker
- Persons with arteriovenous malformations
Show all 16Show fewer
- Chest deformity more complicated than pectus excavatum (e.g., Poland syndrome)
- Persons for whom a foreign body implant would pose a risk (e.g., immunodeficiency)
- Persons at increased risk for general anesthesia (e.g., history of malignant hyperthermia)
- Respiratory conditions that have required steroid treatment (e.g., prednisone) in the last 3 years
- Pregnancy
- Inability to understand or follow instructions
- Refusal to wear the external brace
- Refusal to undergo monthly chest x-rays
- Inability or refusal to return to UCSF for biweekly follow-up visits for the first month after surgery, and monthly thereafter until explant.
- Inability to obtain pre-approval (authorization) from the patient's insurance carrier
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Mercy Hospitals
Kansas City, Missouri, 64108
Shriners Hospitals for Children
Sacramento, California, 95817
UCSF-Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Phase 3 Multicenter Study of Magnetic Mini-Mover for Pectus Excavatum
This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus excavatum uses a magnetically coupled implant to pull the sternum forward and gradually remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of Orphan Products Development (Grant #R01 FD003341).
Read the detailed description
Pectus excavatum is the most common congenital chest wall abnormality in children. The investigators have developed a novel method of achieving gradual deformation/reformation of chest wall cartilage. A magnetic force field is used to apply controlled, sustained force to promote biologic reformation of structural cartilage. A magnet is implanted on the sternum and secured through a 2-inch subxiphoid incision as a one-hour outpatient procedure. The magnet (and sternum) is pulled outward by another magnet suspended in a novel, low-profile, lightweight device previously molded to the patient's anterior chest wall. The low-profile, non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets.
In the single-center, FDA-funded trial (IDE G050196), the investigators tested proof of concept, safety and probable benefit of this procedure in 10. In this Phase III multicenter trial, the investigators will further test the safety and efficacy of the procedure in 15 otherwise healthy patients with moderate-to-severe PE, ages 8 to 14. The investigators will be using the next generation Magnetic Mini-Mover Magnimplant device (IDE G090006), a design the investigators believe is much improved in terms of safety and ease of implantation/explantation. Implantation of the Magnimplant will be accomplished in an outpatient procedure. The investigators will document the rate of correction by comparing chest X-ray measurement of the Pectus Severity Index prior to implantation, to that measured after the magnet is removed. Treatment will last 18-24 months, depending on correction and when the patient has completed his or her pubertal growth spurt, as documented by hand x-ray. Explant of the device will be accomplished in an outpatient procedure. The investigators will document safety with an EKG prior to implantation, one month post-implantation, and finally after the magnet is removed. The investigators will document efficacy by comparing pre- and post-treatment PSI, as well as by evaluating patient satisfaction with a post-procedure Quality of Life-type survey. Long-term follow-up will occur at 6, 12, 18, and 24 months after explantation.
- Conditions
- Pectus Excavatum
- Being tested
- Magnetic Mini-Mover Procedure (Magnimplant)
- Keywords
- Pectus excavatum, Chest wall deformity, Magnetic Mini-Mover Procedure, Pectus Severity Index, pediatric medical device, magnetic alteration, sunken chest
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Mini-Mover Procedure (Magnimplant)Device
Also called IDE G090006
This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery. The Magnimplant or Magnetic Mini-Mover device implant will surgically implanted on the sternum. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo brace treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). Patients will be seen in clinic at least monthly until treatment is complete and the magnimplant device will be explanted from their sternum.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the interventional treatment arm by having outpatient surgery and the Magnetic MIni-Mover Magnimplant procedure is performed during which the magnetic implant is surgically placed. After 2 years of treatment with the implanted magnet and brace treatment, the Magnetic Mini-Mover Magnimplant will be explanted. After surgery and recovery, all subjects will be fitted for an orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). Receives: Device: Magnetic Mini-Mover Procedure (Magnimplant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Reactions
All adverse reactions were recorded and reported, including complications from implantation of the device, complications from application of the external device over time (e.g., changes in skin; infection; changes in cardiac electrical function).
Measured: During treatment, 24 months
Secondary outcomes (3)
Comfort and Brace Wear During Treatment
Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance were be measured throughout treatment. In addition, the satisfaction of the patient and family will be measured using a standard Quality of Life (QOL) questionnaire administered 1 month after implanting the device and 1 month after removing the device.
Measured: During treatment, 24 months
Chest Wall Correction, by Pectus Severity Index
Though not powered to determine efficacy, preliminary efficacy data, as measured by pre and post treatment Pectus Severity Index (Haller Index), was also collected. Pre-treatment Haller Index was assessed based on computed tomography (CT) of the chest. One month after implant removal, patients underwent repeat chest CT to evaluate chest wall correction.
Measured: 24 months
Patient Satisfaction During the Treatment
. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant
Measured: One month and one year after explant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2016
- Study completionMay 2018
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 (3)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Harrison
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children, Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor-investigator, Michael Harrison, University of California, San Francisco
- Investigators
- Michael R Harrison, MD, Study director, University of California, San FranciscoBenjamin Padilla, MD, Principal investigator, University of California, San FranciscoLan Vu, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327274
- Sponsor's protocol ID
- FD003341-03-06
- Other IDs
- FD-R-01FD-03341
- Acronym
- 3MP
- Status last verified
- Oct 2018
- First submitted
- 30 Mar 2011
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: The end results will be published in Journal of Pediatric Surgery June 2017
Publications
Harrison MR, Curran PF, Jamshidi R, Christensen D, Bratton BJ, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum II: initial findings of a Food and Drug Administration-sponsored trial. J Pediatr Surg. 2010 Jan;45(1):185-91; discussion 191-2. doi: 10.1016/j.jpedsurg.2009.10.032.
PubMed 20105602Harrison MR, Estefan-Ventura D, Fechter R, Moran AM Jr, Christensen D. Magnetic Mini-Mover Procedure for pectus excavatum: I. Development, design, and simulations for feasibility and safety. J Pediatr Surg. 2007 Jan;42(1):81-5; discussion 85-6. doi: 10.1016/j.jpedsurg.2006.09.042.
PubMed 17208545Harrison MR, Gonzales KD, Bratton BJ, Christensen D, Curran PF, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum III: safety and efficacy in a Food and Drug Administration-sponsored clinical trial. J Pediatr Surg. 2012 Jan;47(1):154-9. doi: 10.1016/j.jpedsurg.2011.10.039.
PubMed 22244409
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Multicenter Study of Magnetic Mini-Mover for Pectus Excavatum
- ClinicalTrials.gov ID
- NCT01327274
- Acronym / sponsor ID
- 3MP / FD003341-03-06
- Conditions
- Pectus Excavatum
- Keywords
- Pectus excavatum, Chest wall deformity, Magnetic Mini-Mover Procedure, Pectus Severity Index, pediatric medical device, magnetic alteration, sunken chest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Michael HarrisonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children, Children's Mercy Hospital Kansas City
- Study start
- Dec 2011 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Posted 17 May 2018
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 a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus excavatum uses a magnetically coupled implant to pull the sternum forward and gradually remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of Orphan Products Development (Grant #R01 FD003341).
Detailed description
Pectus excavatum is the most common congenital chest wall abnormality in children. The investigators have developed a novel method of achieving gradual deformation/reformation of chest wall cartilage. A magnetic force field is used to apply controlled, sustained force to promote biologic reformation of structural cartilage. A magnet is implanted on the sternum and secured through a 2-inch subxiphoid incision as a one-hour outpatient procedure. The magnet (and sternum) is pulled outward by another magnet suspended in a novel, low-profile, lightweight device previously molded to the patient's anterior chest wall. The low-profile, non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets.
In the single-center, FDA-funded trial (IDE G050196), the investigators tested proof of concept, safety and probable benefit of this procedure in 10. In this Phase III multicenter trial, the investigators will further test the safety and efficacy of the procedure in 15 otherwise healthy patients with moderate-to-severe PE, ages 8 to 14. The investigators will be using the next generation Magnetic Mini-Mover Magnimplant device (IDE G090006), a design the investigators believe is much improved in terms of safety and ease of implantation/explantation. Implantation of the Magnimplant will be accomplished in an outpatient procedure. The investigators will document the rate of correction by comparing chest X-ray measurement of the Pectus Severity Index prior to implantation, to that measured after the magnet is removed. Treatment will last 18-24 months, depending on correction and when the patient has completed his or her pubertal growth spurt, as documented by hand x-ray. Explant of the device will be accomplished in an outpatient procedure. The investigators will document safety with an EKG prior to implantation, one month post-implantation, and finally after the magnet is removed. The investigators will document efficacy by comparing pre- and post-treatment PSI, as well as by evaluating patient satisfaction with a post-procedure Quality of Life-type survey. Long-term follow-up will occur at 6, 12, 18, and 24 months after explantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Magnetic Mini-Mover Procedure (Magnimplant)This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the interventional treatment arm by having outpatient surgery and the Magnetic MIni-Mover Magnimplant procedure is performed during which the magnetic implant is surgically placed. After 2 years of treatment with the implanted magnet and brace treatment, the Magnetic Mini-Mover Magnimplant will be explanted. After surgery and recovery, all subjects will be fitted for an orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Otherwise healthy male or female with pectus excavatum deformity
- Between 8 and 14 years of age (inclusive)
- Pectus Severity Index > 3.5 (normal 2.56). NOTE: A pectus severity index of 3.5 or greater qualifies as a moderate-to-severe deformity, and justifies operative intervention
- Ability to read, speak and understand English
- Onset of rapid growth of puberty documented by hand/wrist x-ray in early to mid-puberty (defined as bone age in females of 7-13 years, and males of 9-14 years)
Key exclusion criteria (16 listed)
- Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum
- Bleeding disorders
- Heart disease (including arrhythmia)
- Persons with active implantable medical devices (AIMD) such as pacemakers
- Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker
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 |
|---|---|---|
| Magnetic Mini-Mover Procedure (Magnimplant)Also: IDE G090006This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery. The Magnimplant or Magnetic Mini-Mover device implant will surgically implanted on the sternum. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo brace treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). Patients will be seen in clinic at least monthly until treatment is complete and the magnimplant device will be explanted from their sternum. | Device | Treatment Arm |
Primary outcome
Number of Participants With Adverse Reactions
Time frame: During treatment, 24 months
All adverse reactions were recorded and reported, including complications from implantation of the device, complications from application of the external device over time (e.g., changes in skin; infection; changes in cardiac electrical function).
3 secondary outcomes
Comfort and Brace Wear During Treatment
Time frame: During treatment, 24 months
Chest Wall Correction, by Pectus Severity Index
Time frame: 24 months
Patient Satisfaction During the Treatment
Time frame: One month and one year after explant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20105602Harrison MR, Curran PF, Jamshidi R, Christensen D, Bratton BJ, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum II: initial findings of a Food and Drug Administration-sponsored trial. J Pediatr Surg. 2010 Jan;45(1):185-91; discussion 191-2. doi: 10.1016/j.jpedsurg.2009.10.032.
- Background: PubMed 17208545Harrison MR, Estefan-Ventura D, Fechter R, Moran AM Jr, Christensen D. Magnetic Mini-Mover Procedure for pectus excavatum: I. Development, design, and simulations for feasibility and safety. J Pediatr Surg. 2007 Jan;42(1):81-5; discussion 85-6. doi: 10.1016/j.jpedsurg.2006.09.042.
- Background: PubMed 22244409Harrison MR, Gonzales KD, Bratton BJ, Christensen D, Curran PF, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum III: safety and efficacy in a Food and Drug Administration-sponsored clinical trial. J Pediatr Surg. 2012 Jan;47(1):154-9. doi: 10.1016/j.jpedsurg.2011.10.039.
- Magnetic Mini-Mover Procedure (3MP) TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. The end results will be published in Journal of Pediatric Surgery June 2017
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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.
Michael R Harrison, MD study director
University of California, San Francisco
Benjamin Padilla, MD principal investigator
University of California, San Francisco
Lan Vu, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Mini-Mover Procedure (Magnimplant) in people with Pectus Excavatum, run by Michael Harrison at 3 sites 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 5 inclusion and 16 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 17 May 2018). 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 Adverse Reactions (time frame: During treatment, 24 months). 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 NCT01327274, which also lists 3 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 8 Nov 2018.