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| ID | Type | Description | Link |
|---|---|---|---|
| PRO00002692 | Other Identifier | University of Florida Project # |
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| Name | Class |
|---|---|
| XDG Technologies, LLC | INDUSTRY |
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The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.
Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost.
The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training.
The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin tag removal initial visit plus follow-up | Experimental | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digiclamp (Skin tag removal initial plus follow-up) | Device | Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-occurrence Rate of Skin Tags | Percentage of subjects who experience a re-occurrence of the skin tag at the removal site. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Permanent Scars Among Lesion Sites | Percentage of subjects who develop a scar at the removal site | 3 months |
| Percentage of Scar Tissue Formation Among Lesion Sites | Percentage of subjects who develop scar tissue or keloid at the site of removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan C Roig, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Raymond Marquette, MD | Ocala | Florida | 34471 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9010187 | Background | Watson BT, Hennrikus WL. Postaxial type-B polydactyly. Prevalence and treatment. J Bone Joint Surg Am. 1997 Jan;79(1):65-8. doi: 10.2106/00004623-199701000-00007. | |
| 14522635 | Background | Schmook T, Stockfleth E. Current treatment patterns in non-melanoma skin cancer across Europe. J Dermatolog Treat. 2003;14 Suppl 3:3-10. doi: 10.1080/jdt.14.s3.3.10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skin Tag Removal Initial Visit Plus Follow-up | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Skin Tag Removal Initial Visit Plus Follow-up | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Re-occurrence Rate of Skin Tags | Percentage of subjects who experience a re-occurrence of the skin tag at the removal site. | Posted | Count of Participants | Participants | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Skin Tag Removal Initial Visit Plus Follow-up | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Roig | University of Florida | 352-273-8985 | roigjc@peds.ufl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2017 | May 25, 2022 | Prot_002.pdf |
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| 3 months |
| Percentage of Discoloration Among Subjects | Percentage of subjects who develop discoloration at the site of removal | 3 months |
| Percentage of Pain/Numbness Where Skin Tag Was Removed | Percentage of subjects who develop pain/numbness at the site of removal | 3 months |
| Satisfaction With Pain Post Procedure | All study participants were asked three questions in a post procedure satisfaction survey. 1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied". Subjects were counted in each category and reported. | 2 months post procedure |
| Satisfaction With What the Area Looked Like Post Procedure | All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were "very satisfied:, "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied" with how the area looks where the skin tag used to be. Subjects in each category were counted and reported. | 2 months post procedure |
| How Likely to Recommend the Procedure to Friends and Family | All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: "very likely", "somewhat likely", "neither likely nor unlikely", "somewhat unlikely", "very unlikely". Subjects in each category were counted and reported. | 2 months post procedure |
| 2438887 | Background | Kahana M, Grossman E, Feinstein A, Ronnen M, Cohen M, Millet MS. Skin tags: a cutaneous marker for diabetes mellitus. Acta Derm Venereol. 1987;67(2):175-7. |
| 3582706 | Background | Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | pounds |
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| Height | Mean | Standard Deviation | inches |
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| Number of lesions | Mean | Standard Deviation | lesions |
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| Location of lesions | Number | lesions |
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| width of lesion | Mean | Standard Deviation | cm |
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| height of lesion | Mean | Standard Deviation | cm |
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| Secondary | Percentage of Permanent Scars Among Lesion Sites | Percentage of subjects who develop a scar at the removal site | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Percentage of Scar Tissue Formation Among Lesion Sites | Percentage of subjects who develop scar tissue or keloid at the site of removal | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Percentage of Discoloration Among Subjects | Percentage of subjects who develop discoloration at the site of removal | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Percentage of Pain/Numbness Where Skin Tag Was Removed | Percentage of subjects who develop pain/numbness at the site of removal | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Satisfaction With Pain Post Procedure | All study participants were asked three questions in a post procedure satisfaction survey. 1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied". Subjects were counted in each category and reported. | Posted | Count of Participants | Participants | 2 months post procedure |
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|
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| Secondary | Satisfaction With What the Area Looked Like Post Procedure | All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were "very satisfied:, "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied" with how the area looks where the skin tag used to be. Subjects in each category were counted and reported. | Posted | Count of Participants | Participants | 2 months post procedure |
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| Secondary | How Likely to Recommend the Procedure to Friends and Family | All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: "very likely", "somewhat likely", "neither likely nor unlikely", "somewhat unlikely", "very unlikely". Subjects in each category were counted and reported. | Posted | Count of Participants | Participants | 2 months post procedure |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Somewhat dissatisfied |
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| Very dissatisfied |
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| Somewhat dissatisfied |
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| Very dissatisfied |
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| Somewhat unlikely |
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| Very unlikely |
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