Clinical trial · Interventional
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
NCT06532955CI-TRIAL-00079353unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
| Lymphedema, Non-Filarial | — | UNRESOLVED | — |
| Lymphedema of Limb | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
| Lymphedema; Surgical | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphaticovenous anastomosis (manual) | Procedure | — | UNRESOLVED |
| Lymphaticovenous anastomosis using Microsure Motion Stabilizer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lymphaticovenous anastomosis using Microsure Motion Stabilizer
- description
- Patients in this group undergo robot-assisted lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 240 minutes.
- interventionNames
- Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer
- type
- ACTIVE_COMPARATOR
- label
- Lymphaticovenous anastomosis
- description
- Patients in this group undergo lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 90 minutes.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender; * Treated for primary early stage breast cancer; * Early stage lymphedema of the arm (stage 1 or 2 on ISL classification); * ELV \> 10%; * Suffering from unilateral disease. Exclusion Criteria: * Male gender; * Stage 3 lymphedema of the arm; * Receiving current breast cancer treatment; * Distant breast cancer metastases; * Current substance abuse; * History of marcaine or indocyanine green allergy; * Non-viable lymphatic system as determined by near infrared imaging; * Previous LVA (\<10 years) in the arm with lymphedema.
References
Publications (2)
- RESULTvan Mulken TJM, Schols RM, Scharmga AMJ, Winkens B, Cau R, Schoenmakers FBF, Qiu SS, van der Hulst RRWJ; MicroSurgical Robot Research Group. First-in-human robotic supermicrosurgery using a dedicated microsurgical robot for treating breast cancer-related lymphedema: a randomized pilot trial. Nat Commun. 2020 Feb 11;11(1):757. doi: 10.1038/s41467-019-14188-w. PMID 32047155
- RESULTJonis, Y.M.J., Profar, J. J. A., van Mulken, T. J. M., & Qiu, S. (2023). The MUSA robot and its applicability in lymphatic surgery. Plastic and Aesthetic Research, 10(29), Article A4. https://doi.org/10.20517/2347-9264.2023.06