Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

Part of paid clinical trials in Glendale, California.

Sponsor
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Study ID
NCT05218044
Status
Recruiting
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Conditions

  • Ductal Carcinoma in Situ

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation — PROCEDURE
    The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Study Details

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

Key Dates

Start date
Nov 1, 2021
Status verified
Mar 2023
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Cryoablation
    Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery.

Primary Outcome Measure

Ability of cryoablation to achieve complete ablation of DCIS [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Office of Dennis R. Holmes, M.D., F.A.C.S.GlendaleCalifornia91206
Dennis Holmes, M.D.
800-203-5515
Dennis Holmes, M.D. (PRINCIPAL_INVESTIGATOR)

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Office of Dennis R. Holmes, M.D., F.A.C.S.· Glendale, CA

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