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NCT03073096
LYMPHA: Eliminating the Burden of Lymphedema in Patients Requiring Nodal Dissection
NA trial testing LVA at time of nodal dissection in Lymph Node Disease in 8 participants. Terminated before completion.
1 June 2019
Quick facts
| Lead sponsor | Ottawa Hospital Research Institute |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 8 |
| Start date | 1 June 2017 |
| Primary completion | 1 June 2019 |
| Estimated completion | 3 June 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- LVA at time of nodal dissection
Conditions studied
- Lymph Node Disease — all drugs for Lymph Node Disease →
Sponsor
Ottawa Hospital Research Institute
Who can join
18 and older, any sex, with Lymph Node Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating swelling. This commonly occurs as a result of a disruption of the lymphatic system during lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an innovative microsurgical technique where blocked lymphatic vessels are drained into the blood circulation by surgically creating a shunt between a lymphatic channel and a blood vessel called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when performed at the time of nodal dissection. We propose a prospective pilot study evaluating the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema rather than to attempt to treat it once it has already progressed and as a result will not only improve the quality of life of the cancer patients, but also decrease health care costs associated with treating lymphedema.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03073096 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ottawa Hospital Research Institute
- Last refreshed: 9 April 2021
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