3MP: Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum

• Sponsor: Michael Harrison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01327274
• Collaborator: Shriners Hospitals for Children (Other), Children's Mercy Hospital Kansas City (Other)
• Enrollment: 15
• Locations: 3
• Arm: 1
• Actual Duration (Months): 77
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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'). 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).

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Device: Magnetic Mini-Mover Procedure (Magnimplant)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Multicenter Study of Magnetic Mini-Mover for Pectus Excavatum
• Actual Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment Arm 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).

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 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.; Other Names: IDE G090006

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Reactions [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).

Secondary Outcome Measures

1. Comfort and Brace Wear During Treatment [During treatment, 24 months]

   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.

2. Chest Wall Correction, by Pectus Severity Index [24 months]

   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.

3. Patient Satisfaction During the Treatment [One month and one year after explant.]

   . Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shriners Hospitals for Children	Sacramento	California	United States	95817
2	UCSF-Benioff Children's Hospital	San Francisco	California	United States	94158
3	Children's Mercy Hospitals	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Michael Harrison
• Shriners Hospitals for Children
• Children's Mercy Hospital Kansas City

Investigators

• Study Director: Michael R Harrison, MD, University of California, San Francisco
• Principal Investigator: Benjamin Padilla, MD, University of California, San Francisco
• Principal Investigator: Lan Vu, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Magnetic Mini-Mover Procedure (3MP) Trial

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.
• Harrison 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.
• Harrison 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.

• Responsible Party: Michael Harrison, Professor of Surgery and Pediatrics, Emeritus, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01327274
• Other Study ID Numbers: FD003341-03-06; FD-R-01FD-03341
• First Posted: Apr 1, 2011
• Last Update Posted: Nov 8, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michael Harrison, Professor of Surgery and Pediatrics, Emeritus, University of California, San Francisco: Pectus excavatum; Chest wall deformity; Magnetic Mini-Mover Procedure; Pectus Severity Index; pediatric medical device; magnetic alteration; sunken chest
• Additional relevant MeSH terms: Funnel Chest

Study Results

Participant Flow

Arm/Group Title	Treatment Arm
Arm/Group Description	This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) underwent the Magnetic Mini-Mover procedure. The internal magnet, or "Magnimplant" was implanted on the sternum. After surgery and recovery, all subjects were fitted for an orthotic brace, the "Magnatract," which is secured to the patient's chest wall by the attractive force between the coupled internal and external magnets and produces an outward force on the sternum to correct the pectus deformity.
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Arm
Arm/Group Description	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 by having outpatient surgery, the Magnetic Mini-Mover procedure, to both place and later explant the experimental Magnimplant or Magnetic Mini-Mover device. 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 24 months. Patients will be seen in clinic at least monthly until treatment is complete.
Overall Participants	15
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	12
Sex: Female, Male (Count of Participants)
Female	2 13.3%
Male	13 86.7%
Race and Ethnicity Not Collected (Count of Participants)
Pectus Severity Index (Haller Index) (Ratio) [Mean (Full Range) ]
Mean (Full Range) [Ratio]	4.7

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Reactions
Description	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).
Time Frame	During treatment, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients who underwent the Magnetic Mini-Mover Procedure
Measure Participants	15
Discharge home same day	13 86.7%
Normal EKG after implant of magnet	15 100%
Surgical site infection	14 93.3%
Intact cables for implant placement	8 53.3%

2. Secondary Outcome

Title	Comfort and Brace Wear During Treatment
Description	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.
Time Frame	During treatment, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients who underwent the Magnetic Mini-Mover Procedure.
Measure Participants	15
Discomfort	5 33.3%
Tolerated Brace wear	10 66.7%

3. Secondary Outcome

Title	Chest Wall Correction, by Pectus Severity Index
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All patients who have received post-treatment chest wall imaging.

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients who underwent the Magnetic Mini-Mover Procedure.
Measure Participants	14
Improved	5 33.3%
No change	2 13.3%
Worsened	7 46.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment Arm
	Comments
	Type of Statistical Test	Other
	Comments	Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.
Statistical Test of Hypothesis	p-Value	0.486
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Patient Satisfaction During the Treatment
Description	. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant
Time Frame	One month and one year after explant.

Outcome Measure Data

Analysis Population Description

14 Participants offered recommendations at 2 time intervals

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients who underwent the Magnetic Mini-Mover Procedure.
Measure Participants	14
Recommend 3MP after 1 month	11 73.3%
Recommend 3MP after 1 year	11 73.3%
Satisfaction with results at 1 month	9 60%
Satisfaction with results after 1 year	8 53.3%

Adverse Events

Time Frame	2 years
Arm/Group Title	Treatment Arm
Arm/Group Description	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 Magnetic Mini-Mover procedure outpatient surgery to both place and later explant the Magnimplant or Magnetic Mini-Mover device. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 24 months.
All Cause Mortality
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)
Cardiac disorders
Nonacute cable breakage requiring explant	1/15 (6.7%)
Product Issues
Acute cable breakage requiring urgent explant	1/15 (6.7%)
Other (Not Including Serious) Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	4/15 (26.7%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/15 (6.7%)
Skin and subcutaneous tissue disorders
Wound infection	1/15 (6.7%)
Rash	1/15 (6.7%)
Surgical and medical procedures
Post-procedure hospitalization for pain control	1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.