NCT01633515

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

June 9, 2012

Last Update Submit

December 2, 2013

Conditions

Basal Cell Carcinoma (BCC)

Keywords

Basal cell carcinoma (BCC)CryotherapyCryosurgery

Outcome Measures

Primary Outcomes (1)

  • Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly

    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

    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).

Study Arms (1)

Intralesional cryotherapy

OTHER

10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications.

Procedure: Intralesional cryotherapy

Interventions

Intralesional cryotherapyPROCEDURE

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).

Also known as: CryoShape; CryoShape™, FDA 510(k) Number K060928)
Intralesional cryotherapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 60 years old
  • BCC was determined with tissue diagnosis in the lower extremity
  • One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.

You may not qualify if:

  • Patient unable to read, understand and sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lin Medical Center

Haifa, Israel

RECRUITING

Related Publications (3)

  • Har-Shai Y, Brown W, Pallua N, Zouboulis CC. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids. Plast Reconstr Surg. 2010 Nov;126(5):1798-1800. doi: 10.1097/PRS.0b013e3181ef823d. No abstract available.

    PMID: 21042160BACKGROUND

  • Har-Shai Y, Brown W, Labbe D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds. 2008 Sep;7(3):169-75. doi: 10.1177/1534734608322813.

    PMID: 18757392BACKGROUND

  • Giuffrida TJ, Jimenez G, Nouri K. Histologic cure of basal cell carcinoma treated with cryosurgery. J Am Acad Dermatol. 2003 Sep;49(3):483-6. doi: 10.1067/s0190-9622(03)00903-4.

    PMID: 12963913BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Yaron Har-Shai, M.D

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaron har-Shai, M.D

CONTACT

972057866206yaron07@yahoo.com

Tamir Gil, M.D

CONTACT

972507308646tamirgiloragil@walla.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of plastic department

Study Record Dates

First Submitted

June 9, 2012

First Posted

July 4, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

IL(1)