Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463613
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-31
Brief Title:
Using a Novel Skin Tag Removal Device
Sponsor:
UK Innovations GP LTD
Organization:
UK Innovations GP LTD
Study Overview
Official Title:
Skin Tag Removal Device A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons Skin Tags
Status:
RECRUITING
Status Verified Date:
2024-06
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 aim of this study is to investigate the use of a mechanical device to remove skin tags in adults
The device Skin Tag Removal or STR utilizes the ligation method by applying a silicone band around the base of a skin tag therefore restricting the blood supply which is vital to its growth and survival Because this method does not include freezing or burning of tissue in or around the skin tag it could be considered less invasive and less risky than other options
The device Skin Tag Removal or STR utilizes the ligation method by applying a silicone band around the base of a skin tag therefore restricting the blood supply which is vital to its growth and survival Because this method does not include freezing or burning of tissue in or around the skin tag it could be considered less invasive and less risky than other options
Detailed Description:
Common benign skin lesions include verruca seborrheic keratoses fibromas histiocytomas dermatofibromas nevi and skin tags acrochordons A skin tag is a small outgrowth of epidermal and dermal tissue and is common among middle-aged adults Their size can range from one to several mm usually flesh-colored and pedunculated Skin tags are exceedingly common benign skin lesions with a reported prevalence of around 45-50 in the general population Typically they are small soft noncancerous fibromas or fibroepithelial polyps bumps of tissue connected to the skins surface by a narrow stalk The color texture size and width of the base can vary
Skin Tags can be removed by a dermatologist using excision cauterization or cryosurgical means Most of these procedures are often done in a dermatology office and are an out-of-pocket cost Recently there is a growing interest is in home-based methods Some devices such as cryo-based cauterization have been cleared for marketing by FDA for over-the-counter OTC use and claimed acceptable removal levels
The STR study devices are designed for the removal of skin tags from the body by ligation of the blood supply to the skin tag through the application of a small elastic band Bands are placed around the base of the skin tag by using an applicator which pushes the band from a cylindrical extension on the device over the skin tag and to the base of the tag
The STR study devices are available in two different sizes to ensure the bands being used are tight enough to restrict the blood supply for skin tags that vary in size The micro version of the STR study device has been designed to remove skin tags that measure 2-4mm at the base and the standard version is designed to remove skin tags that measure 4-6mm at their base
The Investigator is planning to enroll up to 200 subjects who will have the skin tags removed using the STR study devices During the trial each subject will complete a diary to document progress
Skin Tags can be removed by a dermatologist using excision cauterization or cryosurgical means Most of these procedures are often done in a dermatology office and are an out-of-pocket cost Recently there is a growing interest is in home-based methods Some devices such as cryo-based cauterization have been cleared for marketing by FDA for over-the-counter OTC use and claimed acceptable removal levels
The STR study devices are designed for the removal of skin tags from the body by ligation of the blood supply to the skin tag through the application of a small elastic band Bands are placed around the base of the skin tag by using an applicator which pushes the band from a cylindrical extension on the device over the skin tag and to the base of the tag
The STR study devices are available in two different sizes to ensure the bands being used are tight enough to restrict the blood supply for skin tags that vary in size The micro version of the STR study device has been designed to remove skin tags that measure 2-4mm at the base and the standard version is designed to remove skin tags that measure 4-6mm at their base
The Investigator is planning to enroll up to 200 subjects who will have the skin tags removed using the STR study devices During the trial each subject will complete a diary to document progress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None