Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Regenerative peripheral nerve interface RPNI was first developed in 2012 by Dr Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds In the decade that followed it was found RPNI surgery not only provided amputees with neuroma a growth made up nerve tissue pain relief but could help prevent neuroma from developing as well
This single center randomized controlled investigator-initiated study will look at whether the RPNI a nerve burying procedure involving protecting sensory nerves with a small piece of the patients pectoralis muscle performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent andor reduce the risk for long-term nerve pain after breast cancer surgery also called neuroma-related post-breast surgery pain syndrome PBSPS versus the standard surgery alone Control group Symptoms of PBSPS include discomfort numbness tingling and shooting pain in the chest and breast area It is relatively common and may have many causes
About 200 adult females 18-65 years old who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study Those who agree and sign the informed consent form will be randomized in 11 fashion 5050 chance to either the RPNI group or the no RPNI Control group Study participants will complete self-reported surveys pre-surgery and at Months 1 3 6 and 12 post-surgery designed to measure pain levels quality of life and function before and after surgery Study participation will last approximately 12 months Subjects will remain blinded to their assigned study arm until their study participation has concluded
This single center randomized controlled investigator-initiated study will look at whether the RPNI a nerve burying procedure involving protecting sensory nerves with a small piece of the patients pectoralis muscle performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent andor reduce the risk for long-term nerve pain after breast cancer surgery also called neuroma-related post-breast surgery pain syndrome PBSPS versus the standard surgery alone Control group Symptoms of PBSPS include discomfort numbness tingling and shooting pain in the chest and breast area It is relatively common and may have many causes
About 200 adult females 18-65 years old who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study Those who agree and sign the informed consent form will be randomized in 11 fashion 5050 chance to either the RPNI group or the no RPNI Control group Study participants will complete self-reported surveys pre-surgery and at Months 1 3 6 and 12 post-surgery designed to measure pain levels quality of life and function before and after surgery Study participation will last approximately 12 months Subjects will remain blinded to their assigned study arm until their study participation has concluded
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None