Computer-Assisted Versus Manual Hair Harvest Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Restoration Robotics, Inc.
ClinicalTrials.gov Identifier:
NCT00926211
First received: June 19, 2009
Last updated: January 3, 2012
Last verified: September 2011
Results First Received: September 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Androgenetic Alopecia
Interventions: Device: ARTAS™ System
Procedure: Manual Hair Harvest

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from June 19, 2009 to September 23, 2010 at hair restoration clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once enrolled, subjects were scheduled for the treatment procedure. Subjects were randomized at the time of the treatment procedure.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Computer-Assisted and Manual Harvest  
STARTED     36 [1]
COMPLETED     35  
NOT COMPLETED     1  
Lost to Follow-up                 1  
[1] One additional subject was not randomized and did not receive the treatment procedure.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Computer-Assisted and Manual Harvest  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.6  ± 7.5  
Gender  
[units: participants]
 
Female     0  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
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1.  Primary:   Increase in Hair Follicles Present   [ Time Frame: Change from Baseline at 9 Months ]

2.  Secondary:   Proportion of Harvested Follicles Transected   [ Time Frame: Time of harvest (Baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Miguel Canales, M.D.
Organization: Restoration Robotics
phone: 650-965-3612 ext 206
e-mail: miguel@restorationrobotics.com


No publications provided


Responsible Party: Restoration Robotics, Inc.
ClinicalTrials.gov Identifier: NCT00926211     History of Changes
Other Study ID Numbers: RR-09-0002
Study First Received: June 19, 2009
Results First Received: September 23, 2011
Last Updated: January 3, 2012
Health Authority: United States: Food and Drug Administration