Evaluating Factors In Study Experiences of Lymphedema Patients
Study Details
Study Description
Brief Summary
The study intends to investigate the personal experiences of lymphedema patients who take part in a separate clinical trial including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.
The data collected from this study will help improve future outcomes for all lymphedema patients as well as those in under-represented demographic groups.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Number of patients who decide to enroll in a lymphedema clinical trial [3 months]
- Rate of patients who remain in lymphedema clinical trial to trial completion [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with lymphedema
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Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
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Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.
Exclusion Criteria:
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Refusal of consent
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Women of childbearing potential without a negative pregnancy test; or women who are lactating.
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Any serious and/or unstable pre-existing medical disorders
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Power Life Sciences | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Boccardo F, Santori G, Villa G, Accogli S, Dessalvi S. Long-term patency of multiple lymphatic-venous anastomoses in cancer-related lymphedema: A single center observational study. Microsurgery. 2022 Oct;42(7):668-676. doi: 10.1002/micr.30944. Epub 2022 Aug 2.
- Johansson K, Blom K, Nilsson-Wikmar L, Brogardh C. Early Intervention with a Compression Sleeve in Mild Breast Cancer-Related Arm Lymphedema: A 12-Month Prospective Observational Study. Cancers (Basel). 2023 May 9;15(10):2674. doi: 10.3390/cancers15102674.
- Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.
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