LymphedemaCLEARNCT07311876
Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
A study testing Symani Surgical System in people with Lymphedema and Lymphedema of Face, run by MMI (Medical Microinstruments, Inc.) at 1 site in Germany.
Trial summary
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lymphedema, Lymphedema of Face, Internal Lymphedema
- What is being tested?
- Symani Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jun 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 22 years of age
- Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
- Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic-assisted procedure
- Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck
- Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
- Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified
- Investigator deems the candidate acceptable for lymphatic reconstruction with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
- Willingness to comply with recommended regimen of self-care, with consistent use of manual lymph drainage and/or appropriately sized compression garments from screening through the entire study duration (through the 6-month follow-up visit).
Who cannot join
- Patient who is incapable and/or unwilling to provide informed consent
- Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
- Active systemic infection under treatment with intravenous antibiotics
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
Show all 14Show fewer
- A history of malignancy or cancer treatment within the past 6 months (tumor control)
- Patient with unsatisfactory manual lymphatic drainage and/or compression garments for at least six months
- Patient with prior lymphatic reconstruction in the targeted head \& neck area
- Patient's lymphatic disease is due to lipedema
- Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema (e.g., thrombosis in the external or internal jugular vein)
- Current infection in the head \& neck area in which lymphedema is present
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- Patient is ineligible to participate for other reasons in the judgement of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Schleswig-Holstein
Kiel, 24105
Martin Laudien, +49 431 500 21715, martin.laudien@uksh.de
Henning Wieker
About this study
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.
- Conditions
- Lymphedema, Lymphedema of Face, Internal Lymphedema, External Lymphedema, Lymphedema of Neck
- Being tested
- Symani Surgical System
- Keywords
- lymphedema, head and neck lymphedema, symani
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani Surgical SystemDevice
Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Lymphedema | Experimental | The patients selected for the CLEAR Study will be adults over 22 years of age with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck. Receives: Device: Symani Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative anastomosis patency prior to closure.
Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis using indocyanine green (ICG) fluorescence imaging and will be evaluated prior to closure of the procedure site during the index procedure.
Measured: The duration of the participants' index procedure.
Freedom from device-related adverse events
All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure.
Measured: The duration of the participants' index procedure through 30 days.
Secondary outcomes (10)
Change in flow pathways
Change in flow pathways will be assessed by an ICG lymphangiography
Measured: From the pre-operative visit through 6 months post index procedure.
Change in MD Anderson Lymphedema Rating Scale for facial lymphedema
Scale ranges from 0-3, the higher score indicating worse disease state.
Measured: From the pre-operative visit through 6 months post index procedure.
Assessment of Lymphedema of the Head and Neck Area (ALOHA) method for lymphedema measurement
Measured: From the pre-operative visit through 6 months post index procedure.
Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory
It contains 33 items (symptoms) which are answered Yes or No. If the response is Yes to any given item, the patient is asked to rate the intensity of the symptom on a 5-point Likert scale. Each symptom then receives a score ranging from 0 (does not experience the symptom) to 5 (experiences the symptom with severe intensity).
Measured: From the pre-operative visit through 6 months post index procedure.
Change in internal lymphedema
Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination
Measured: From the pre-operative visit through 6 months post index procedure.
Technical Success
as freedom from any device malfunction resulting in unplanned conventional (manual) suturing
Measured: The duration of the participants' index procedure.
All-cause readmission rates
Measured: The duration of the participants' index procedure through 30 days post index proceudre.
Procedure-related adverse events (AEs) rate
Measured: The duration of the participants' index procedure through 30 days post index proceudre.
Serious adverse events (AEs) rate
Measured: The duration of the participants' index procedure through 30 days post index proceudre.
Anastomosis-specific reoperation rate
Measured: The duration of the participants' index procedure through 30 days post index proceudre.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start19 Jun 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Laudien, Principal investigator, University Hospital Schleswig-HolsteinJamie Ku, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311876
- Sponsor's protocol ID
- CDC-00148
- Acronym
- CLEAR
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
- ClinicalTrials.gov ID
- NCT07311876
- Acronym / sponsor ID
- CLEAR / CDC-00148
- Conditions
- Lymphedema, Lymphedema of Face, Internal Lymphedema, External Lymphedema, Lymphedema of Neck
- Keywords
- lymphedema, head and neck lymphedema, symani
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 31 Dec 2025 (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.
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Lymphedema | Experimental | Device: Symani Surgical SystemThe patients selected for the CLEAR Study will be adults over 22 years of age with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 22 years of age
- Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
- Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic-assisted procedure
- Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck
- Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
Key exclusion criteria (14 listed)
- Patient who is incapable and/or unwilling to provide informed consent
- Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
- Active systemic infection under treatment with intravenous antibiotics
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
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 |
|---|---|---|
| Symani Surgical SystemSymani® Surgical System is intended to perform surgical techniques during open microsurgical procedures. | Device | Head and Neck Lymphedema |
Primary outcome
Intraoperative anastomosis patency prior to closure.
Time frame: The duration of the participants' index procedure.
Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis using indocyanine green (ICG) fluorescence imaging and will be evaluated prior to closure of the procedure site during the index procedure.
Freedom from device-related adverse events
Time frame: The duration of the participants' index procedure through 30 days.
All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure.
10 secondary outcomes
Change in flow pathways
Time frame: From the pre-operative visit through 6 months post index procedure.
Change in MD Anderson Lymphedema Rating Scale for facial lymphedema
Time frame: From the pre-operative visit through 6 months post index procedure.
Assessment of Lymphedema of the Head and Neck Area (ALOHA) method for lymphedema measurement
Time frame: From the pre-operative visit through 6 months post index procedure.
Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory
Time frame: From the pre-operative visit through 6 months post index procedure.
Change in internal lymphedema
Time frame: From the pre-operative visit through 6 months post index procedure.
Technical Success
Time frame: The duration of the participants' index procedure.
All-cause readmission rates
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Procedure-related adverse events (AEs) rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Serious adverse events (AEs) rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Anastomosis-specific reoperation rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
Martin Laudien principal investigator
University Hospital Schleswig-Holstein
Jamie Ku principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symani Surgical System in people with Lymphedema and Lymphedema of Face, run by MMI (Medical Microinstruments, Inc.) at 1 site in Germany.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (8336646276 ext. 5, clinical.ops@mmimicro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative anastomosis patency prior to closure. (time frame: The duration of the participants' index procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.