Trial Outcomes & Findings for Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum (NCT NCT01327274)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

During treatment, 24 months

Results posted on

2018-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm 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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=15 Participants 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.
Age, Continuous	12 years n=15 Participants
Sex: Female, Male Female	2 Participants n=15 Participants
Sex: Female, Male Male	13 Participants n=15 Participants
Pectus Severity Index (Haller Index)	4.7 Ratio n=15 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=15 Participants All patients who underwent the Magnetic Mini-Mover Procedure
Number of Participants With Adverse Reactions Discharge home same day	13 Participants
Number of Participants With Adverse Reactions Normal EKG after implant of magnet	15 Participants
Number of Participants With Adverse Reactions Surgical site infection	14 Participants
Number of Participants With Adverse Reactions Intact cables for implant placement	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=15 Participants All patients who underwent the Magnetic Mini-Mover Procedure
Comfort and Brace Wear During Treatment Tolerated Brace wear	10 Participants
Comfort and Brace Wear During Treatment Discomfort	5 Participants

SECONDARY outcome

Timeframe: 24 months

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

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=14 Participants All patients who underwent the Magnetic Mini-Mover Procedure
Chest Wall Correction, by Pectus Severity Index Improved	5 Participants
Chest Wall Correction, by Pectus Severity Index No change	2 Participants
Chest Wall Correction, by Pectus Severity Index Worsened	7 Participants

SECONDARY outcome

Timeframe: One month and one year after explant.

Population: 14 Participants offered recommendations at 2 time intervals

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=14 Participants All patients who underwent the Magnetic Mini-Mover Procedure
Patient Satisfaction During the Treatment Recommend 3MP after 1 month	11 Participants
Patient Satisfaction During the Treatment Recommend 3MP after 1 year	11 Participants
Patient Satisfaction During the Treatment Satisfaction with results at 1 month	9 Participants
Patient Satisfaction During the Treatment Satisfaction with results after 1 year	8 Participants

Adverse Events

Treatment Arm

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=15 participants at risk 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.
Product Issues Acute cable breakage requiring urgent explant	6.7% 1/15 • 2 years
Cardiac disorders Nonacute cable breakage requiring explant	6.7% 1/15 • 2 years

Other adverse events

Other adverse events
Measure	Treatment Arm n=15 participants at risk 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.
Surgical and medical procedures Post-procedure hospitalization for pain control	6.7% 1/15 • 2 years
Skin and subcutaneous tissue disorders Wound infection	6.7% 1/15 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.7% 1/15 • 2 years
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • 2 years

Additional Information

Jill Imamura-Ching, RN

UCSF Benioff Children's Hospital

Phone: 415-476-3446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60