Computer-Assisted Versus Manual Hair Harvest Comparative Study

• Sponsor: Restoration Robotics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00926211
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 18.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The objective of this clinical study is to investigate and compare the safety and efficacy of the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle harvesting method following a nine-month period of post-procedural evaluation.

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Device: ARTAS™ System; Procedure: Manual Hair Harvest	N/A

Detailed Description

A major technical step in hair transplantation is harvesting of the hair follicles. There are two accepted techniques for obtaining the hair grafts that are transplanted during the procedure. The first is donor strip harvest and stereomicroscopic dissection of the follicular unit grafts. The second is dissection and extraction of the follicular unit graft directly from the patient's scalp referred to as Follicular Unit Extraction or "FUE". Potential benefits of the FUE technique may be less scalp scarring in the Donor Area, less patient discomfort and faster wound healing. Although the FUE approach to harvest has highly desirable attributes, it is technically difficult to perform, labor intensive, tedious and requires an excessive amount of time to harvest follicular units. These procedural factors have prevented the FUE approach from gaining wider adoption.

Restoration Robotics, Inc. has developed the Restoration Robotics ARTAS™ Computer-Assisted Harvesting System to assist physicians in the harvest of hair follicles during hair transplantation procedures. The System mimics the manual FUE approach to harvesting follicular units and has the potential to solve the technical challenges inherent in the manual FUE technique. The ARTAS™ System is capable of identifying and harvesting hair follicles directly from the patient's scalp through a semi-automated process. The goal of the ARTAS™ System is to harvest the hair follicles while maintaining their critical anatomic structures intact.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Computer-Assisted Hair harvest using the computer-assisted system	Device: ARTAS™ System; Hair harvest using a computer-assisted system
Active Comparator: Manual Harvest Hair harvesting via manual technique	Procedure: Manual Hair Harvest; Hair harvesting via the manual technique

Outcome Measures

Primary Outcome Measures

1. Increase in Hair Follicles Present [Change from Baseline at 9 Months]

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

Secondary Outcome Measures

1. Proportion of Harvested Follicles Transected [Time of harvest (Baseline)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 59 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject is male with clinical diagnosis of androgenic alopecia with Norwood-Hamilton grade of IV-VII

• Subject is 30 to 59 years old

• Subject has black or brown hair color

• Subject has straight hair

• Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation

• Subject agrees to have two dot tattoos placed on scalp

• Subject is able to understand and provide written consent; and

• Subject consents to post-operative follow-up per protocol.

Exclusion Criteria:

• Subject has preponderance of grey/white hair

• Subject has blonde hair

• Subject has red hair

• Subject uses hair dye

• Subject has prior history of hair restoration procedure(s) using the strip excision technique

• Subject has prior history of scalp reduction surgery(s)

• Subject has helical hair (curly hair)

• Subject has wavy hair

• Subject has bleeding diathesis

• Subject has active use of anti-coagulation medication

• Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study

• Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or

• Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berman Skin Institute	Palo Alto	California	United States	94304
2	A Practice of Hair Restoration	Walnut Creek	California	United States	94596

Sponsors and Collaborators

• Restoration Robotics, Inc.

Investigators

• Study Director: Miguel Canales, M.D., Restoration Robotics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Restoration Robotics, Inc.
• ClinicalTrials.gov Identifier: NCT00926211
• Other Study ID Numbers: RR-09-0002
• First Posted: Jun 23, 2009
• Last Update Posted: Jan 5, 2012
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Alopecia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from June 19, 2009 to September 23, 2010 at hair restoration clinics.
Pre-assignment Detail	Once enrolled, subjects were scheduled for the treatment procedure. Subjects were randomized at the time of the treatment procedure.

Arm/Group Title	Computer-Assisted and Manual Harvest
Arm/Group Description	Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
Period Title: Overall Study
STARTED	36
COMPLETED	35
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Computer-Assisted and Manual Harvest
Arm/Group Description	Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
Overall Participants	36
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.6 (7.5)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	36 100%
Region of Enrollment (participants) [Number]
United States	36 100%

Outcome Measures

1. Primary Outcome

Title	Increase in Hair Follicles Present
Description	The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.
Time Frame	Change from Baseline at 9 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Harvest	Computer-Assisted Harvest
Arm/Group Description	Region of scalp with implanted follicles that were manually harvested.	Region of scalp with implanted follicles that were harvested using a computer-assisted system.
Measure Participants	36	36
Mean (Standard Deviation) [Hair follicles]	16.9 (18.3)	18.3 (18.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Manual Harvest, Computer-Assisted Harvest
	Comments	The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.
Statistical Test of Hypothesis	p-Value	0.023
	Comments	t-test comparison to the upper limit of the non-inferiority margin
	Method	t-test, 1 sided
	Comments	Paired t-test compared to the non-inferiority margin of 4 follicles.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.4
	Confidence Interval	(1-Sided) 97.5%; to 3.9
	Parameter Dispersion	Type: Standard Deviation; Value: 15.5
	Estimation Comments	The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.

2. Secondary Outcome

Title	Proportion of Harvested Follicles Transected
Description	The proportion of harvested hair follicles that were transected by each harvest method.
Time Frame	Time of harvest (Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Harvest	Computer-Assisted Harvest
Arm/Group Description	Region of scalp with implanted follicles that were manually harvested.	Region of scalp with implanted follicles that were harvested using a computer-assisted system.
Measure Participants	36	35
Mean (Standard Deviation) [Proportion of transected follicles]	.264 (.112)	.219 (.146)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Manual Harvest, Computer-Assisted Harvest
	Comments	Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Study was powered for the primary efficacy outcome.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	Paired t-test.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.045
	Confidence Interval	(1-Sided) 97.5%; -.004 to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.146
	Estimation Comments

Adverse Events

Time Frame	9 months
Arm/Group Title	Computer-Assisted and Manual Harvest
Arm/Group Description	Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
All Cause Mortality
	Computer-Assisted and Manual Harvest
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Computer-Assisted and Manual Harvest
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Other (Not Including Serious) Adverse Events
	Computer-Assisted and Manual Harvest
	Affected / at Risk (%)	# Events
Total	0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.