Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 5:44 AM
Study NCT ID:
NCT06317766
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histological Study of the Effects of a 2910 nm Fiber Laser Technology
Sponsor:
FA Corporation
Organization:
Study Overview
Official Title:
Histological Study of the Effects of a 2910 nm Fiber Laser Technology
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.
Part 1 Pre-Clinical Study Procedure:
* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.
Part 2 Clinical Study Procedure:
* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* The study team will utilize the specific setting based off the results of Part 1.
* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.
* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.
* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.
Part 1 Pre-Clinical Study Procedure:
* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.
Part 2 Clinical Study Procedure:
* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* The study team will utilize the specific setting based off the results of Part 1.
* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.
* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.
* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: