Cryoablation for Post Mastectomy Pain Syndrome



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:January 10, 2018
End Date:July 2019
Contact:Maria Rivas
Email:mrivas2@emory.edu
Phone:404-712-7962

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Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome

This is a prospective, randomized, parallel-group, treatment control trial with cross-over
options performed at four sites. The purpose of this study is to assess the efficacy and
safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

This is a prospective, randomized, parallel-group, treatment control trial with cross-over
options performed at four sites. The purpose of this study is to assess the efficacy and
safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

Participants will be randomized to receive cryoablation or a therapeutic peripheral nerve
block injection (tPNB). All participants will be evaluated at baseline and after treatment at
10 days, 90 days, and 180 days via clinical visits.

The option to undergo cryoablation or tPNB will be offered to all participants at the end of
the 90 day post-procedure assessment. Each subject that elects the crossover intervention
will be assessed over the same time period and in an identical fashion to the initial
intervention, including a final long term follow up (LTFU) assessment at 180 days
post-cryoablation.

Inclusion Criteria:

- Status post breast surgical intervention, to include mastectomy, partial mastectomy,
lumpectomy, or reconstruction

- Persistent pain in the distribution of the Intercostobrachial nerve: the residual
breast, surgical bed, ipsilateral medial arm, and/or axilla following tissue healing
(> 1 month postoperative)

- Positive response to local anesthetic nerve block, performed under imaging guidance. A
positive response is defined as a ≥ 3 point change on a standard 11 point visual
analog scale (VAS)

- Ability and willingness to provide informed consent

Exclusion Criteria:

- Active infection

- Underlying cervical segmentation or other cervical spinal anomaly that results in
differential nerve root pressures

- Immunosuppression

- Uncorrectable coagulopathy

- Currently pregnant, nursing or planning to become pregnant.
We found this trial at
4
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Phone: 404-712-7962
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-712-7962
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, Georgia 30342
Phone: 404-712-7962
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Johns Creek, Georgia 30097
Phone: 404-712-7962
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Johns Creek, GA
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