LymphedemaNCT06191081
Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis
An observational study of Lymphedema, run by Taizhou Hospital at 1 site in China.
Trial summary
The aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- lymphaticovenous anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Oct 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months
Who may be able to join
- lymphedema Paitent
Who cannot join
- myoedema Paitent；lipedema Paitent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis in Upper Limb Extremity Lymphedema
The aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema.
Read the detailed description
By analyzing the size of lymphatic vessels (0.3-0.6mm), ICG imaging, contraction characteristics of lymphatic vessels and lymphatic flow in patients with lymphedema, the effect of functional lymphatic vessel selection on lymphatic drainage in patients with lymphedema was judged during operation, so as to provide a more scientific basis for the selection of functional lymphatic vessels in clinical surgery.
- Conditions
- Lymphedema
- Being tested
- lymphaticovenous anastomosis
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphaticovenous anastomosisProcedure or surgery
lymphaticovenous anastomosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of size(0.3-0.6mm)
size of lymphatic vessels
Measured: through study completion, an average of 2.5 year
Rate of lymphatic vessels contractility
When observing lymphatic vessels in fluorescence mode, a contraction occurring within 10 seconds is considered as contractility positive
Measured: through study completion, an average of 2.5 year
Rate of flow
while the presence of lymphatic fluid flowing out after cutting the lymphatic vessel is considered as flow positive
Measured: through study completion, an average of 2.5 year
Rate of ICG
When observing lymphatic vessels in fluorescence mode, lymphatic vessel fluorescence is considered as ICG positive
Measured: through study completion, an average of 2.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Oct 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- youmao liu, Study director, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191081
- Sponsor's protocol ID
- FLV20231208
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis in Upper Limb Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT06191081
- Acronym / sponsor ID
- FLV20231208
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 5 Jan 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.
The aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema.
Detailed description
By analyzing the size of lymphatic vessels (0.3-0.6mm), ICG imaging, contraction characteristics of lymphatic vessels and lymphatic flow in patients with lymphedema, the effect of functional lymphatic vessel selection on lymphatic drainage in patients with lymphedema was judged during operation, so as to provide a more scientific basis for the selection of functional lymphatic vessels in clinical surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months
Key inclusion criteria (1 listed)
- lymphedema Paitent
Key exclusion criteria (1 listed)
- myoedema Paitent；lipedema Paitent
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 anastomosislymphaticovenous anastomosis | Procedure or surgery | – |
Primary outcome
Rate of size(0.3-0.6mm)
Time frame: through study completion, an average of 2.5 year
size of lymphatic vessels
Rate of lymphatic vessels contractility
Time frame: through study completion, an average of 2.5 year
When observing lymphatic vessels in fluorescence mode, a contraction occurring within 10 seconds is considered as contractility positive
Rate of flow
Time frame: through study completion, an average of 2.5 year
while the presence of lymphatic fluid flowing out after cutting the lymphatic vessel is considered as flow positive
Rate of ICG
Time frame: through study completion, an average of 2.5 year
When observing lymphatic vessels in fluorescence mode, lymphatic vessel fluorescence is considered as ICG positive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
youmao liu study director
employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Taizhou Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of size(0.3-0.6mm) (time frame: through study completion, an average of 2.5 year). The study lists 4 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 5 Jan 2024.