Trial Outcomes & Findings for Magnetic Mini-Mover Procedure to Treat Pectus Excavatum (NCT NCT00466206)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

One month post-explantation

Results posted on

2016-01-01

Participant Flow

Physician- or self-referral to the Chest Wall Deformity Clinic at UCSF for evaluation of pectus excavatum. Active recruitment from 2007-2009 to accrue ten subjects.

Participant milestones

Participant milestones
Measure	3MP Treatment Arm Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Mini-Mover Procedure to Treat Pectus Excavatum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3MP Treatment Arm n=10 Participants Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	12.7 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: One month post-explantation

Population: Per protocol, this is a single-arm, pilot study of ten subjects.

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.

Outcome measures

Outcome measures
Measure	Magnetic Mini-Mover Group n=10 Participants Treatment for pectus excavatum using Magnimplant and Magnatract
Affect on Cardiac Activity	0 participants

PRIMARY outcome

Timeframe: One-month post-explant

Population: Per protocol

Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear

Outcome measures

Outcome measures
Measure	Magnetic Mini-Mover Group n=10 Participants Treatment for pectus excavatum using Magnimplant and Magnatract
Damage/Discoloration to Skin	0 participants

PRIMARY outcome

Timeframe: One year post-explant

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Magnetic Mini-Mover Group n=10 Participants Treatment for pectus excavatum using Magnimplant and Magnatract
Efficacy: Patient Satisfaction	3.7 Scores on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: One year post-explanation

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Magnetic Mini-Mover Group n=10 Participants Treatment for pectus excavatum using Magnimplant and Magnatract
Efficacy: Patient Recommendation of Treatment	4.2 Scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 18 months active Rx

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Magnetic Mini-Mover Group n=10 Participants Treatment for pectus excavatum using Magnimplant and Magnatract
Patient Compliance	16 avg hours per day brace worn Interval 11.0 to 23.0

Adverse Events

Magnetic Mini-Mover Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Magnetic Mini-Mover Treatment n=10 participants at risk Use of the Magnimplant and Magnatract to treat pectus excavatum
Surgical and medical procedures Wound infection	30.0% 3/10 • Number of events 3 • 3 years
Surgical and medical procedures Re-operation	50.0% 5/10 • Number of events 6 • 3 years

Additional Information

Michael Harrison, MD

UCSF-Benioff Children's Hospital

Phone: 415 476-2538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place