New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

NCT ID: NCT05324202

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-30

Brief Summary

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The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.

Detailed Description

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Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nd:YAG treatment arm

Group Type OTHER

Cynosure Cynergy Nd:YAG Laser 1064nm

Intervention Type DEVICE

The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).

Interventions

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Cynosure Cynergy Nd:YAG Laser 1064nm

The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients with one or more basal cell carcinoma(s) on head, trunk or extremities

* Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
* H zone \<6mm, M zone \<10mm, L zone \<20mm
* Tumor thickness \<2mm
* Clearly visible margins

Exclusion Criteria

* Pregnancy
* \<18 years of age
* Current or history of immunosuppression
* Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
* History of radiation in the area of basal cell carcinoma appearance
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Stephanie Geisler

OTHER

Sponsor Role lead

Responsible Party

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Dr. Stephanie Geisler

Investigator, Resident in Dermatology

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Ndyag_BCC_1

Identifier Type: -

Identifier Source: org_study_id

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