LymphedemaNCT06532955
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
A study testing Lymphaticovenous anastomosis using Microsure Motion Stabilizer and Lymphaticovenous anastomosis (manual) in people with Lymphedema and Lymphedema Arm, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- What is being tested?
- Lymphaticovenous anastomosis using Microsure Motion Stabilizer and Lymphaticovenous anastomosis (manual)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center+
Maastricht, Limburg, 6229HX
Alieske Kleeven, MSc, +31(0)433877481, alieske.kleeven@mumc.nl
Shan Shan Qiu Shao, MSc, PhD
About this study
Official title: Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
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.
Read the detailed description
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.
It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during \& complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema; Surgical, Lymphedema, Secondary
- Being tested
- Lymphaticovenous anastomosis using Microsure Motion Stabilizer, Lymphaticovenous anastomosis (manual)
- Keywords
- Robot-assisted microsurgery, Microsurgery, Robot, Robotic-assisted, Robot-assisted, Lymphaticovenous anastomosis, Lymphatico-venular anastomosis, LVA
- Medical subject headings
- Lymphedema, Neoplasm Metastasis, Breast Cancer Lymphedema, Non-Filarial Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphaticovenous anastomosis using Microsure Motion StabilizerDevice
Also called LVA, Lympahticovenular anastomosis, Lymphovenous bypass, Lymphatic-venous shunt
The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin.
The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.
Lymphaticovenous anastomosis (manual)Procedure or surgery
Also called LVA, Lymphaticovenous anastomosis, Lymphovenous bypass, Lymphatic-venous shunt
Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema
| Study group | Role | What they receive |
|---|---|---|
| Lymphaticovenous anastomosis using Microsure Motion Stabilizer | Experimental | 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. Receives: Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer |
| Lymphaticovenous anastomosis | Active comparator | 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. Receives: Procedure: Lymphaticovenous anastomosis (manual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of lymphaticovenous anastomosis (LVA)
Efficiency of LVA is measured assessing the quality of the LVA using video recordings of the surgery, which is judged by two independent consultants. The Structured Assessment of Microsurgery Skills (SAMS) measuring method is used to assess the quality of each anastomosis. The SAMS score contains twelve separate items, scored from 1 (bad) to 5 (excellent), grouped into four areas (dexterity, visuo-spatial ability, operative flow and judgement), each subdivided into three technical components.
Measured: Assessed at one moment during, maximally up to 1 year postoperatively
Secondary outcomes (9)
Duration of the surgery
The total duaton of the surgery is from the moment of exploration to find adequate lymph channels and venules to the time to finish the LVA anastomoses during surgery. It is hypothesised that robot assisted surgery will have an equal duration of surgery. The increased precision will compensate the initial extra time for settin up the robotic system
Measured: Assessed once and registered directly after the surgery
Errors during surgery
The SAMS list of peri-operative 'complications' (technical flaws) are judged by the two blinded consultants. The surgeon and research team will also register a list of peri-operative (technical) problems
Measured: Assessed during surgery and registered directly after the surgery on the same day as the surgery
Perioperative complications
The surgeon and research team will register a list of peri-operative complications, as well as complications during the full follow-up period.
Measured: Assessed during surgery and postoperatively, in case any occur
Surgeon's satisfaction with the procedure
Is assessed using a ten point Visual Analogue Score. The higher the score, the higher the satisfaction of the surgeon.
Measured: Assessed directly after surgery, on the same day as the surgery
Surgeon's learning curve with the procedure in practise
To study the learning curve will be calculated by using a curve fitting method to model learning curves.
Measured: Assessed through study completion, an average of 1 year
Patient's convenience during the surgery
Patients' overall convenience during the surgery is assessed using a ten point Visual Analogye Score. The higher the score, the more the patient had experienced during surgery. Moreover, patients are asked to fill in if peculiar matters had occurred which might help to increase the patients overall experience during surgery.
Measured: Assessed directly postoperatively,on the same day as the surgery
Arm circumference over time
Arm circumference is assessed by measuring both arms using the Upper Extremity Lymphedema (UEL) index. The arm is measured at 10 and 5 centimeters above and below the elbow, at the elbow, wrist and dorsum of the hand.
Measured: At baseline, 3, 6, and 12 months following LVA
Arm volume over time
Water volumetry assess the arm volume over time
Measured: At baseline, 3, 6, and 12 months following LVA
Patient's symptoms over time
The Lymphoedema Functioning, Disability and Health (Lymph-ICF) questionnaire assesses physical function, mental function, household activities, mobility activities, and life and social activities. This questionnaire is filled in to evaluate the effect of the LVA surgery and is part of the general evaluation of LVA patients. The questionnaire takes approximately five minutes and consists of 29 questions. The score ranges from 0 to 100, with 0 being the highest healthrelated quality of life.
Measured: At baseline, 3, 6 and 12 months following LVA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jun 2017
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan Shan Qiu Shao, MSc, PhD, Principal investigator, Maastricht University Medical CenterTom van Mulken, MSc, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532955
- Sponsor's protocol ID
- NL60199.068.16
- Other IDs
- METC162053
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be published under an Open Access license, making them accesible to everyone at all times. Requests for sharing individual participant data (IPD) will be evaluated on a case-by-case basis, assessing them for suitable research purposes following the trial's completion.
Publications
van 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.
PubMed 32047155Jonis, 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
- ClinicalTrials.gov ID
- NCT06532955
- Acronym / sponsor ID
- NL60199.068.16
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema; Surgical, Lymphedema, Secondary
- Keywords
- Robot-assisted microsurgery, Microsurgery, Robot, Robotic-assisted, Robot-assisted, Lymphaticovenous anastomosis, Lymphatico-venular anastomosis, LVA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.
It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during \& complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphaticovenous anastomosis using Microsure Motion Stabilizer | Experimental | Device: Lymphaticovenous anastomosis using Microsure Motion StabilizerPatients 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. |
| Lymphaticovenous anastomosis | Active comparator | Procedure: Lymphaticovenous anastomosis (manual)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Male gender;
- Stage 3 lymphedema of the arm;
- Receiving current breast cancer treatment;
- Distant breast cancer metastases;
- Current substance abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphaticovenous anastomosis using Microsure Motion StabilizerAlso: LVA, Lympahticovenular anastomosis, Lymphovenous bypass, Lymphatic-venous shuntThe robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin. The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure. | Device | Lymphaticovenous anastomosis using Microsure Motion Stabilizer |
| Lymphaticovenous anastomosis (manual)Also: LVA, Lymphaticovenous anastomosis, Lymphovenous bypass, Lymphatic-venous shuntLymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema | Procedure or surgery | Lymphaticovenous anastomosis |
Primary outcome
Efficiency of lymphaticovenous anastomosis (LVA)
Time frame: Assessed at one moment during, maximally up to 1 year postoperatively
Efficiency of LVA is measured assessing the quality of the LVA using video recordings of the surgery, which is judged by two independent consultants. The Structured Assessment of Microsurgery Skills (SAMS) measuring method is used to assess the quality of each anastomosis. The SAMS score contains twelve separate items, scored from 1 (bad) to 5 (excellent), grouped into four areas (dexterity, visuo-spatial ability, operative flow and judgement), each subdivided into three technical components.
9 secondary outcomes
Duration of the surgery
Time frame: Assessed once and registered directly after the surgery
Errors during surgery
Time frame: Assessed during surgery and registered directly after the surgery on the same day as the surgery
Perioperative complications
Time frame: Assessed during surgery and postoperatively, in case any occur
Surgeon's satisfaction with the procedure
Time frame: Assessed directly after surgery, on the same day as the surgery
Surgeon's learning curve with the procedure in practise
Time frame: Assessed through study completion, an average of 1 year
Patient's convenience during the surgery
Time frame: Assessed directly postoperatively,on the same day as the surgery
Arm circumference over time
Time frame: At baseline, 3, 6, and 12 months following LVA
Arm volume over time
Time frame: At baseline, 3, 6, and 12 months following LVA
Patient's symptoms over time
Time frame: At baseline, 3, 6 and 12 months following LVA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Results publication: PubMed 32047155van 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.
- Results publicationJonis, 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
- Individual participant dataSharing planned: Yes. The results will be published under an Open Access license, making them accesible to everyone at all times. Requests for sharing individual participant data (IPD) will be evaluated on a case-by-case basis, assessing them for suitable research purposes following the trial's completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Shan Qiu Shao, MSc, PhD principal investigator
Maastricht University Medical Center
Tom van Mulken, MSc study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphaticovenous anastomosis using Microsure Motion Stabilizer and Lymphaticovenous anastomosis (manual) in people with Lymphedema and Lymphedema Arm, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alieske Kleeven, MSc (+31(0)433877481, alieske.kleeven@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of lymphaticovenous anastomosis (LVA) (time frame: Assessed at one moment during, maximally up to 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06532955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.