Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01633515|
Recruitment Status : Unknown
Verified December 2013 by Yaron Har-Shai, Carmel Medical Center.
Recruitment status was: Recruiting
First Posted : July 4, 2012
Last Update Posted : December 3, 2013
A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma (BCC)||Procedure: Intralesional cryotherapy||Not Applicable|
BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.
surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||July 2014|
10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications.
Procedure: Intralesional cryotherapy
The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn.
Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).
Other Name: CryoShape; CryoShape™, FDA 510(k) Number K060928)
- Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly [ Time Frame: Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received). ]Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633515
|Contact: Yaron har-Shai, M.Dfirstname.lastname@example.org|
|Contact: Tamir Gil, M.Demail@example.com|
|Lin Medical Center||Recruiting|
|Principal Investigator:||Yaron Har-Shai, M.D||Carmel Medical Center|