Pectus ExcavatumPhase 1/23MPNCT00466206
Magnetic Mini-Mover Procedure to Treat Pectus Excavatum
A Phase 1/2 study testing Magnetic Mini-Mover Procedure (3MP), Magnatract (external magnet in a removable external brace) and 3MP (Magnetic Mini-Mover Procedure) in people with Pectus Excavatum, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a medical research study. The study investigators have developed a method to gradually repair pectus excavatum (sunken chest) deformity by placing a magnet on the sternum (breastbone) and then applying an external magnetic force that will pull the sternum outward gradually. 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 (3MP), Magnatract (external magnet in a removable external brace) and 3MP (Magnetic Mini-Mover Procedure)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2011
- Phase
- Phase 1/2
- 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
- Resident of the U.S.;
- Otherwise healthy male or female with pectus excavatum deformity;
- Between 8 and 14 years of age;
- Pectus Severity Index > 3.5 (normal 2.56); and
- Ability to read and speak English.
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 15Show 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;
- Inability to obtain pre-approval (authorization) from the patient's insurance carrier; and
- Inability or refusal to return to UCSF for weekly follow-up visits for the first month after surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143-0570
About this study
Official title: Phase II Magnetic Alteration of Pectus Excavatum
This is a medical research study.
The study investigators have developed a method to gradually repair pectus excavatum (sunken chest) deformity by placing a magnet on the sternum (breastbone) and then applying an external magnetic force that will pull the sternum outward gradually.
Read more
Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are seeking corrective surgery for their condition. They will be residents of the U.S. and between the ages of 8 and 14 years of age. Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity.
The purpose of this study is to test what effects, good and/or bad, placing an external/internal magnetic device has on correcting pectus excavatum deformity in children, and the safety of using such a device for treatment.
Read the detailed description
Pectus excavatum is the most common congenital chest wall abnormality in children. Surgical correction requires a big operation under general anesthesia which forces the sternum forward and holds it in place using a metal chest wall strut. Deformation of the chest wall under great pressure may result in complications and potential relapses as well as postoperative pain requiring hospitalization for regional and narcotic anesthesia for up to a week. An alternative principle for correction of chest wall and other deformities is gradual (bit-by-bit) correction using minimal force applied over many months (like moving teeth with orthodontic braces).
The hypothesis of this study is that constant outward force on the deformed cartilage in pectus excavatum will produce biologic reformation of cartilage and correction of the chest wall deformity.
The study investigators have developed a novel method of achieving gradual deformation/reformation of chest wall cartilage without the need for transdermal orthopedic devices or repeated surgeries. A magnetic force field is used to apply controlled, sustained force to promote biologic reformation of structural cartilage (the same principle as distraction osteogenesis). A magnet is implanted on the sternum and secured using a novel fixation strategy that can be accomplished through a 3-cm subxyphoid incision as a brief 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 external magnet allows individual adjustment in small increments of the distance (and, thus, force) and orientation of the force applied to the sternum. The low-profile, non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets.
The study objectives are to test the safety and probable benefit of this procedure in 10 otherwise healthy, young patients, between 8 years and 14 years of age, who have chosen to have this deformity corrected using this novel technique rather than the standard Ravitch or Nuss techniques. We will document the rate of correction by chest imaging and measurement of the Pectus Severity Index. The study investigators will document safety and efficacy with an EKG prior to implantation, one month post-implantation, and finally after the magnet is removed, as well as patient and family satisfaction with a post-procedure Quality of Life-type survey.
- Conditions
- Pectus Excavatum
- Being tested
- Magnetic Mini-Mover Procedure (3MP), Magnatract (external magnet in a removable external brace), 3MP (Magnetic Mini-Mover Procedure)
- Keywords
- pectus excavatum, magnetic alteration, chest wall deformity
- 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 (3MP)Device
Also called 3MP
A rare earth magnet encased in FDA-approved titanium will be implanted securely on the outer surface of the lower end of the sternum in patients with pectus excavatum. This is accomplished as an outpatient procedure, under brief general anesthesia.
A 2-inch transverse skinline incision is made at the junction of the sternum and xyphoid and the space in front and behind the sternum is dissected bluntly. The titanium can containing the magnet is securely fixed to the sternum by screwing it into a titanium fixation disk in front of the sternum. The procedure takes 1/2-hour, and the patient can go home the same day.
In another outpatient procedure, the Magnimplant is explanted 18 months after implantation.
Magnatract (external magnet in a removable external brace)Device
Also called Magnetic Mini-mover
An external orthotic device "Magnatract" which includes an external magnet in a removable brace is fitted specifically to the patient's chest wall deformity. A calibrated meter in the external device measures the force applied between the two magnets. When the patient and family are comfortable with the device and comfort and skin condition have been assessed, the patient will be allowed to take the Magnatract home and begin the process of gradually advancing the sternum forward as the abnormal costal cartilage is reformed.
3MP (Magnetic Mini-Mover Procedure)Procedure or surgery
Also called 3MP
- Subject has EKG performed to measure baseline cardiac activity.
- Magnimplant is implanted.
- After one week, "Magnatract" is fitted.
- Chest x-ray and 2nd EKG performed 30 days post-implantation.
- Patient and parents complete QoL questionnaire 30d post-implantation.
- Patient seen weekly for first month post-implantation to assess comfort and skin condition. Thereafter, will be seen monthly.
- At each monthly visit, patient will have lateral and anterior-posterior chest X-rays to monitor sternal correction.
- At each visit data logger is downloaded to measure strength of pull since last visit and amount of wear-time.
- Magnimplant explanted 18 months later as 1/2-hr outpatient procedure.
- CT scan and third EKG performed after explanation.
- Patient and parents complete QOL questionnaires after explantation and 1 yr post-explantation.
| Study group | Role | What they receive |
|---|---|---|
| 3MP - Treatment Arm | Experimental | Magnetic Mini-Mover Procedure using the Magnimplant and Magnatract Receives: Device: Magnetic Mini-Mover Procedure (3MP); Device: Magnatract (external magnet in a removable external brace); Procedure: 3MP (Magnetic Mini-Mover Procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect on Cardiac Activity
EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.
Measured: One month post-explantation
Damage/Discoloration to Skin
Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear
Measured: One-month post-explant
Efficacy: Patient Satisfaction
Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied
Measured: One year post-explant
Efficacy: Patient Recommendation of Treatment
Based on patient response to one-year post-explantation QoL statement: "I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum." Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree
Measured: One year post-explanation
Secondary outcomes (1)
Patient Compliance
Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic
Measured: 18 months active Rx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2010
- Study completionApr 2011
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 (19)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- FDA Office of Orphan Products Development
- Responsible party
- Principal investigator, Michael Harrison, University of California, San Francisco
- Investigators
- Michael R Harrison, MD, Principal investigator, University of California, San Francisco Medical Center and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466206
- Sponsor's protocol ID
- FD 003341
- Acronym
- 3MP
- Status last verified
- Dec 2015
- First submitted
- 24 Apr 2007
- Last updated
- 1 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
RAVITCH MM. The operative treatment of pectus excavatum. J Pediatr. 1956 Apr;48(4):465-72. doi: 10.1016/s0022-3476(56)80075-9. No abstract available.
PubMed 13295996WELCH KJ. Satisfactory surgical correction of pectus excavatum deformity in childhood; a limited opportunity. J Thorac Surg. 1958 Nov;36(5):697-713. No abstract available.
PubMed 13588724Morshuis WJ, Mulder H, Wapperom G, Folgering HT, Assman M, Cox AL, van Lier HJ, Vincent JG, Lacquet LK. Pectus excavatum. A clinical study with long-term postoperative follow-up. Eur J Cardiothorac Surg. 1992;6(6):318-28; discussion 328-9. doi: 10.1016/1010-7940(92)90149-r.
PubMed 1616728ADKINS PC, BLADES B. A stainless steel strut for correction of pectus escavatum. Surg Gynecol Obstet. 1961 Jul;113:111-3. No abstract available.
PubMed 13681493Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
PubMed 8641129Nuss D, Croitoru DP, Kelly RE Jr, Goretsky MJ, Nuss KJ, Gustin TS. Review and discussion of the complications of minimally invasive pectus excavatum repair. Eur J Pediatr Surg. 2002 Aug;12(4):230-4. doi: 10.1055/s-2002-34485.
PubMed 12368998Beiser GD, Epstein SE, Stampfer M, Goldstein RE, Noland SP, Levitsky S. Impairment of cardiac function in patients with pectus excavatum, with improvement after operative correction. N Engl J Med. 1972 Aug 10;287(6):267-72. doi: 10.1056/NEJM197208102870602. No abstract available.
PubMed 5038952Lawson ML, Cash TF, Akers R, Vasser E, Burke B, Tabangin M, Welch C, Croitoru DP, Goretsky MJ, Nuss D, Kelly RE Jr. A pilot study of the impact of surgical repair on disease-specific quality of life among patients with pectus excavatum. J Pediatr Surg. 2003 Jun;38(6):916-8. doi: 10.1016/s0022-3468(03)00123-4.
PubMed 12778393Wynn SR, Driscoll DJ, Ostrom NK, Staats BA, O'Connell EJ, Mottram CD, Telander RL. Exercise cardiorespiratory function in adolescents with pectus excavatum. Observations before and after operation. J Thorac Cardiovasc Surg. 1990 Jan;99(1):41-7.
PubMed 2294364Haller JA Jr, Loughlin GM. Cardiorespiratory function is significantly improved following corrective surgery for severe pectus excavatum. Proposed treatment guidelines. J Cardiovasc Surg (Torino). 2000 Feb;41(1):125-30.
PubMed 10836238Zhao L, Feinberg MS, Gaides M, Ben-Dov I. Why is exercise capacity reduced in subjects with pectus excavatum? J Pediatr. 2000 Feb;136(2):163-7. doi: 10.1016/s0022-3476(00)70096-5.
PubMed 10657820Mead J, Sly P, Le Souef P, Hibbert M, Phelan P. Rib cage mobility in pectus excavatum. Am Rev Respir Dis. 1985 Dec;132(6):1223-8. doi: 10.1164/arrd.1985.132.6.1223.
PubMed 4073662Shamberger RC. Cardiopulmonary effects of anterior chest wall deformities. Chest Surg Clin N Am. 2000 May;10(2):245-52, v-vi.
PubMed 10803331Malek MH, Fonkalsrud EW, Cooper CB. Ventilatory and cardiovascular responses to exercise in patients with pectus excavatum. Chest. 2003 Sep;124(3):870-82. doi: 10.1378/chest.124.3.870.
PubMed 12970011Hebra A, Swoveland B, Egbert M, Tagge EP, Georgeson K, Othersen HB Jr, Nuss D. Outcome analysis of minimally invasive repair of pectus excavatum: review of 251 cases. J Pediatr Surg. 2000 Feb;35(2):252-7; discussion 257-8. doi: 10.1016/s0022-3468(00)90019-8.
PubMed 10693675
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Magnetic Alteration of Pectus Excavatum
- ClinicalTrials.gov ID
- NCT00466206
- Acronym / sponsor ID
- 3MP / FD 003341
- Conditions
- Pectus Excavatum
- Keywords
- pectus excavatum, magnetic alteration, chest wall deformity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- FDA Office of Orphan Products Development
- Study start
- Apr 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Posted 3 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a medical research study.
The study investigators have developed a method to gradually repair pectus excavatum (sunken chest) deformity by placing a magnet on the sternum (breastbone) and then applying an external magnetic force that will pull the sternum outward gradually.
Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are seeking corrective surgery for their condition. They will be residents of the U.S. and between the ages of 8 and 14 years of age. Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity.
The purpose of this study is to test what effects, good and/or bad, placing an external/internal magnetic device has on correcting pectus excavatum deformity in children, and the safety of using such a device for treatment.
Detailed description
Pectus excavatum is the most common congenital chest wall abnormality in children. Surgical correction requires a big operation under general anesthesia which forces the sternum forward and holds it in place using a metal chest wall strut. Deformation of the chest wall under great pressure may result in complications and potential relapses as well as postoperative pain requiring hospitalization for regional and narcotic anesthesia for up to a week. An alternative principle for correction of chest wall and other deformities is gradual (bit-by-bit) correction using minimal force applied over many months (like moving teeth with orthodontic braces).
The hypothesis of this study is that constant outward force on the deformed cartilage in pectus excavatum will produce biologic reformation of cartilage and correction of the chest wall deformity.
The study investigators have developed a novel method of achieving gradual deformation/reformation of chest wall cartilage without the need for transdermal orthopedic devices or repeated surgeries. A magnetic force field is used to apply controlled, sustained force to promote biologic reformation of structural cartilage (the same principle as distraction osteogenesis). A magnet is implanted on the sternum and secured using a novel fixation strategy that can be accomplished through a 3-cm subxyphoid incision as a brief 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 external magnet allows individual adjustment in small increments of the distance (and, thus, force) and orientation of the force applied to the sternum. The low-profile, non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets.
The study objectives are to test the safety and probable benefit of this procedure in 10 otherwise healthy, young patients, between 8 years and 14 years of age, who have chosen to have this deformity corrected using this novel technique rather than the standard Ravitch or Nuss techniques. We will document the rate of correction by chest imaging and measurement of the Pectus Severity Index. The study investigators will document safety and efficacy with an EKG prior to implantation, one month post-implantation, and finally after the magnet is removed, as well as patient and family satisfaction with a post-procedure Quality of Life-type survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3MP - Treatment Arm | Experimental | Device: Magnetic Mini-Mover Procedure (3MP), Device: Magnatract (external magnet in a removable external brace), Procedure: 3MP (Magnetic Mini-Mover Procedure)Magnetic Mini-Mover Procedure using the Magnimplant and Magnatract |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Resident of the U.S.;
- Otherwise healthy male or female with pectus excavatum deformity;
- Between 8 and 14 years of age;
- Pectus Severity Index > 3.5 (normal 2.56); and
- Ability to read and speak English.
Key exclusion criteria (15 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 (3MP)Also: 3MPA rare earth magnet encased in FDA-approved titanium will be implanted securely on the outer surface of the lower end of the sternum in patients with pectus excavatum. This is accomplished as an outpatient procedure, under brief general anesthesia. A 2-inch transverse skinline incision is made at the junction of the sternum and xyphoid and the space in front and behind the sternum is dissected bluntly. The titanium can containing the magnet is securely fixed to the sternum by screwing it into a titanium fixation disk in front of the sternum. The procedure takes 1/2-hour, and the patient can go home the same day. In another outpatient procedure, the Magnimplant is explanted 18 months after implantation. | Device | 3MP - Treatment Arm |
| Magnatract (external magnet in a removable external brace)Also: Magnetic Mini-moverAn external orthotic device "Magnatract" which includes an external magnet in a removable brace is fitted specifically to the patient's chest wall deformity. A calibrated meter in the external device measures the force applied between the two magnets. When the patient and family are comfortable with the device and comfort and skin condition have been assessed, the patient will be allowed to take the Magnatract home and begin the process of gradually advancing the sternum forward as the abnormal costal cartilage is reformed. | Device | 3MP - Treatment Arm |
| 3MP (Magnetic Mini-Mover Procedure)Also: 3MP* Subject has EKG performed to measure baseline cardiac activity. * Magnimplant is implanted. * After one week, "Magnatract" is fitted. * Chest x-ray and 2nd EKG performed 30 days post-implantation. * Patient and parents complete QoL questionnaire 30d post-implantation. * Patient seen weekly for first month post-implantation to assess comfort and skin condition. Thereafter, will be seen monthly. * At each monthly visit, patient will have lateral and anterior-posterior chest X-rays to monitor sternal correction. * At each visit data logger is downloaded to measure strength of pull since last visit and amount of wear-time. * Magnimplant explanted 18 months later as 1/2-hr outpatient procedure. * CT scan and third EKG performed after explanation. * Patient and parents complete QOL questionnaires after explantation and 1 yr post-explantation. | Procedure or surgery | 3MP - Treatment Arm |
Primary outcome
Affect on Cardiac Activity
Time frame: One month post-explantation
EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.
Damage/Discoloration to Skin
Time frame: One-month post-explant
Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear
Efficacy: Patient Satisfaction
Time frame: One year post-explant
Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied
Efficacy: Patient Recommendation of Treatment
Time frame: One year post-explanation
Based on patient response to one-year post-explantation QoL statement: "I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum." Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree
1 secondary outcome
Patient Compliance
Time frame: 18 months active Rx
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 13295996RAVITCH MM. The operative treatment of pectus excavatum. J Pediatr. 1956 Apr;48(4):465-72. doi: 10.1016/s0022-3476(56)80075-9. No abstract available.
- Background: PubMed 13588724WELCH KJ. Satisfactory surgical correction of pectus excavatum deformity in childhood; a limited opportunity. J Thorac Surg. 1958 Nov;36(5):697-713. No abstract available.
- Background: PubMed 1616728Morshuis WJ, Mulder H, Wapperom G, Folgering HT, Assman M, Cox AL, van Lier HJ, Vincent JG, Lacquet LK. Pectus excavatum. A clinical study with long-term postoperative follow-up. Eur J Cardiothorac Surg. 1992;6(6):318-28; discussion 328-9. doi: 10.1016/1010-7940(92)90149-r.
- Background: PubMed 13681493ADKINS PC, BLADES B. A stainless steel strut for correction of pectus escavatum. Surg Gynecol Obstet. 1961 Jul;113:111-3. No abstract available.
- Background: PubMed 8641129Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
- Background: PubMed 12368998Nuss D, Croitoru DP, Kelly RE Jr, Goretsky MJ, Nuss KJ, Gustin TS. Review and discussion of the complications of minimally invasive pectus excavatum repair. Eur J Pediatr Surg. 2002 Aug;12(4):230-4. doi: 10.1055/s-2002-34485.
- Background: PubMed 5038952Beiser GD, Epstein SE, Stampfer M, Goldstein RE, Noland SP, Levitsky S. Impairment of cardiac function in patients with pectus excavatum, with improvement after operative correction. N Engl J Med. 1972 Aug 10;287(6):267-72. doi: 10.1056/NEJM197208102870602. No abstract available.
- Background: PubMed 12778393Lawson ML, Cash TF, Akers R, Vasser E, Burke B, Tabangin M, Welch C, Croitoru DP, Goretsky MJ, Nuss D, Kelly RE Jr. A pilot study of the impact of surgical repair on disease-specific quality of life among patients with pectus excavatum. J Pediatr Surg. 2003 Jun;38(6):916-8. doi: 10.1016/s0022-3468(03)00123-4.
- Background: PubMed 2294364Wynn SR, Driscoll DJ, Ostrom NK, Staats BA, O'Connell EJ, Mottram CD, Telander RL. Exercise cardiorespiratory function in adolescents with pectus excavatum. Observations before and after operation. J Thorac Cardiovasc Surg. 1990 Jan;99(1):41-7.
- Background: PubMed 10836238Haller JA Jr, Loughlin GM. Cardiorespiratory function is significantly improved following corrective surgery for severe pectus excavatum. Proposed treatment guidelines. J Cardiovasc Surg (Torino). 2000 Feb;41(1):125-30.
- Background: PubMed 10657820Zhao L, Feinberg MS, Gaides M, Ben-Dov I. Why is exercise capacity reduced in subjects with pectus excavatum? J Pediatr. 2000 Feb;136(2):163-7. doi: 10.1016/s0022-3476(00)70096-5.
- Background: PubMed 4073662Mead J, Sly P, Le Souef P, Hibbert M, Phelan P. Rib cage mobility in pectus excavatum. Am Rev Respir Dis. 1985 Dec;132(6):1223-8. doi: 10.1164/arrd.1985.132.6.1223.
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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 principal investigator
University of California, San Francisco Medical Center and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnetic Mini-Mover Procedure (3MP), Magnatract (external magnet in a removable external brace) and 3MP (Magnetic Mini-Mover Procedure) in people with Pectus Excavatum, run by University of California, San Francisco at 1 site 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 15 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 1 Jan 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2012). 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?
Affect on Cardiac Activity (time frame: One month post-explantation). The study lists 4 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 NCT00466206, which also lists 19 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 1 Jan 2016.