Androgenic AlopeciaNCT02914587
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
A study testing ARTAS System and Manual Implantation in people with Androgenic Alopecia, run by Restoration Robotics, Inc. at 1 site in United States.
Trial summary
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation. Read more about this study
- Who is it for?
- Ages 29 to 70 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- ARTAS System and Manual Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
- Subject is 29 to 70 years old;
- Subject has black or brown hair color;
- Subject has straight hair;
- Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
- Subject agrees to have 6 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 prior history of scalp reduction surgery(s);
- Subject has prior history of hair restoration procedure(s) using the strip excision technique;
- 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
1 site in 1 country.
About this study
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.
Read the detailed description
This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.
The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.
Patients will be followed for a nine months period of time.
- Conditions
- Androgenic Alopecia
- Being tested
- ARTAS System, Manual Implantation
- 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
Manual ImplantationOther
| Study group | Role | What they receive |
|---|---|---|
| ARTAS System | Experimental | Implantation with the ARTAS System. Receives: Device: ARTAS System |
| Manual Implantation | Active comparator | Implantation manually. Receives: Other: Manual Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Survival rate 9-months post procedure
Hair survival rate
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restoration Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914587
- Sponsor's protocol ID
- CP-003
- Status last verified
- Feb 2017
- First submitted
- 19 Sep 2016
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
- ClinicalTrials.gov ID
- NCT02914587
- Acronym / sponsor ID
- CP-003
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Restoration Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.
Detailed description
This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.
The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.
Patients will be followed for a nine months period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARTAS System | Experimental | Device: ARTAS SystemImplantation with the ARTAS System. |
| Manual Implantation | Active comparator | Other: Manual ImplantationImplantation manually. |
Who may qualify
- Ages
- 29 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
- Subject is 29 to 70 years old;
- Subject has black or brown hair color;
- Subject has straight hair;
- Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
Key exclusion criteria (7 listed)
- Subject has prior history of scalp reduction surgery(s);
- Subject has prior history of hair restoration procedure(s) using the strip excision technique;
- 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;
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 System | Device | ARTAS System |
| Manual Implantation | Other | Manual Implantation |
Primary outcome
Hair Survival rate 9-months post procedure
Time frame: 9 month
Hair survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Implantation in people with Androgenic Alopecia, run by Restoration Robotics, Inc. at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Hair Survival rate 9-months post procedure (time frame: 9 month). 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 13 Feb 2017.