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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with lymphedema who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | (415) 900-4227 | bask@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | Power Life Sciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Power Life Sciences | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24931830 | Background | 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. | |
| 35916247 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2023 | Jul 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 37345010 | Background | 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. |