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Идёт набор NCT06382272

A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

Без фазы С лечением Mastectomy Breast Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bionic Breast implant.
Кому может быть актуально
Состояния в реестре: Mastectomy, Breast, Chronic Pain. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy

Обзор

This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.

Вмешательства

  • Устройство Bionic Breast implant
    A small medical device will be temporarily implanted in one of the breasts at the time of the mastectomy. This device is capable of sending very small electrical currents to the nerves that can deliver sensory stimulation in response to touch and pressure applied to the breast

Первичные конечные точки

  • Psychophysical tasks to assess stimulation-elicited sensation [Срок оценки: 7 months after mastectomy+implantation and removal of device]
Вторичные конечные точки (5)
  • Maximum stimulation level [Срок оценки: 7 months after mastectomy+implantation and removal of device]
  • Amplitude discrimination task [Срок оценки: 7 months after mastectomy+implantation and removal of device]
  • Frequency discrimination task [Срок оценки: 7 months after mastectomy+implantation and removal of device]
  • Magnitude estimation [Срок оценки: 7 months after mastectomy+implantation and removal of device]
  • Projected field mapping [Срок оценки: 7 months after mastectomy+implantation and removal of device]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM
  • Bilateral mastectomy for unilateral in situ or T1to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.
  • Agrees to have breast tissue expander removed within 12-20 weeks of implantation.
  • Has access to a cell phone and willing to provide the research interviewer with the cell phone number
  • Agrees to receive text messages from the study
  • Able to speak and understand English or Spanish
  • Able to participate in the informed consent process

Критерии исключения

  • Requires adjuvant chemotherapy
  • Single stage mastectomy and reconstruction procedure
  • Clinical evidence of bilateral breast cancer
  • Clinical evidence of lymph node involvement
  • Prior history of mastectomy or other major breast surgery
  • Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)
  • Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast
  • Pregnant or intending to become pregnant during the study period
  • Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes
  • Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia
  • Uncontrolled diabetes
  • History of poor wound healing or chronic skin ulcerations
  • History of uncontrolled infection or active infection at time of consent
  • Expectation that MRI will be required while the devices are implanted
  • Inability or unwillingness to follow verbal instructions and comply with study procedures
  • Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons
  • Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Chicago Medicine Comprehensive Cancer Center — Chicago

Идентификаторы

NCT: NCT06382272 · IRB23-2027 · 5R01CA281301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗