Trial Outcomes & Findings for Computer-Assisted Versus Manual Hair Harvest Comparative Study (NCT NCT00926211)

Results Overview

The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

Change from Baseline at 9 Months

Results posted on

2012-01-05

Participant Flow

Subjects were recruited from June 19, 2009 to September 23, 2010 at hair restoration clinics.

Once enrolled, subjects were scheduled for the treatment procedure. Subjects were randomized at the time of the treatment procedure.

Participant milestones

Participant milestones
Measure	Computer-Assisted and Manual Harvest Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Computer-Assisted and Manual Harvest Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Computer-Assisted Versus Manual Hair Harvest Comparative Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Computer-Assisted and Manual Harvest n=36 Participants Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	48.6 years STANDARD_DEVIATION 7.5 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Region of Enrollment United States	36 participants n=93 Participants

PRIMARY outcome

Timeframe: Change from Baseline at 9 Months

Population: The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.

The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.

Outcome measures

Outcome measures
Measure	Manual Harvest n=36 Participants Region of scalp with implanted follicles that were manually harvested.	Computer-Assisted Harvest n=36 Participants Region of scalp with implanted follicles that were harvested using a computer-assisted system.
Increase in Hair Follicles Present	16.9 Hair follicles Standard Deviation 18.3	18.3 Hair follicles Standard Deviation 18.0

SECONDARY outcome

Timeframe: Time of harvest (Baseline)

The proportion of harvested hair follicles that were transected by each harvest method.

Outcome measures

Outcome measures
Measure	Manual Harvest n=36 Participants Region of scalp with implanted follicles that were manually harvested.	Computer-Assisted Harvest n=35 Participants Region of scalp with implanted follicles that were harvested using a computer-assisted system.
Proportion of Harvested Follicles Transected	.264 Proportion of transected follicles Standard Deviation .112	.219 Proportion of transected follicles Standard Deviation .146

Adverse Events

Computer-Assisted and Manual Harvest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miguel Canales, M.D.

Restoration Robotics

Phone: 650-965-3612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place