Androgenetic AlopeciaNCT00926211
Computer-Assisted Versus Manual Hair Harvest Comparative Study
A study testing ARTAS™ System and Manual Hair Harvest in people with Androgenetic Alopecia, run by Restoration Robotics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- ARTAS™ System and Manual Hair Harvest
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Berman Skin Institute
Palo Alto, California, 94304
A Practice of Hair Restoration
Walnut Creek, California, 94596
About this study
Official title: Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study
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.
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- ARTAS™ System, Manual Hair Harvest
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTAS™ SystemDevice
Hair harvest using a computer-assisted system
Manual Hair HarvestProcedure or surgery
Hair harvesting via the manual technique
| Study group | Role | What they receive |
|---|---|---|
| Computer-Assisted | Experimental | Hair harvest using the computer-assisted system Receives: Device: ARTAS™ System |
| Manual Harvest | Active comparator | Hair harvesting via manual technique Receives: Procedure: Manual Hair Harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Hair Follicles Present
The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.
Measured: Change from Baseline at 9 Months
Secondary outcomes (1)
Proportion of Harvested Follicles Transected
The proportion of harvested hair follicles that were transected by each harvest method.
Measured: Time of harvest (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restoration Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Canales, M.D., Study director, Restoration Robotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926211
- Sponsor's protocol ID
- RR-09-0002
- Status last verified
- Sep 2011
- First submitted
- 19 Jun 2009
- Last updated
- 5 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study
- ClinicalTrials.gov ID
- NCT00926211
- Acronym / sponsor ID
- RR-09-0002
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Restoration Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 8 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-Assisted | Experimental | Device: ARTAS™ SystemHair harvest using the computer-assisted system |
| Manual Harvest | Active comparator | Procedure: Manual Hair HarvestHair harvesting via manual technique |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTAS™ SystemHair harvest using a computer-assisted system | Device | Computer-Assisted |
| Manual Hair HarvestHair harvesting via the manual technique | Procedure or surgery | Manual Harvest |
Primary outcome
Increase in Hair Follicles Present
Time frame: 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.
1 secondary outcome
Proportion of Harvested Follicles Transected
Time frame: Time of harvest (Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Canales, M.D. study director
Restoration Robotics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTAS™ System and Manual Hair Harvest in people with Androgenetic Alopecia, run by Restoration Robotics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Hair Follicles Present (time frame: Change from Baseline at 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.