An interventional study of Symani Surgical System in Lymphedema, Lymphedema of Face and Internal Lymphedema, sponsored by MMI (Medical Microinstruments, Inc.). Recruiting at 1 site in Germany. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by MMI (Medical Microinstruments, Inc.) · Not applicable, Interventional, and Treatment
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →MMI (Medical Microinstruments, Inc.) is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Symani Surgical System
Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.
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.
Time frame: 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.
Time frame: The duration of the participants' index procedure through 30 days.
Change in flow pathways
Change in flow pathways will be assessed by an ICG lymphangiography
Time frame: 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.
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
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).
Time frame: From the pre-operative visit through 6 months post index procedure.
Change in internal lymphedema
Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination
Time frame: 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
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.
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MMI (Medical Microinstruments, Inc.)