NCT06191081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

December 10, 2023

Last Update Submit

December 19, 2023

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (4)

  • Rate of size(0.3-0.6mm)

    size of lymphatic vessels

    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

    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

    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

    through study completion, an average of 2.5 year

Interventions

lymphaticovenous anastomosisPROCEDURE

lymphaticovenous anastomosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months

You may qualify if:

  • lymphedema Paitent

You may not qualify if:

  • myoedema Paitent；lipedema Paitent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chong Liu

Zhejiang, China

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • youmao liu

    employee

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 10, 2023

First Posted

January 5, 2024

Study Start

January 1, 2022

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations

CN(1)