LymphedemaEarly Phase 1NCT02020837

A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

A Early Phase 1 study testing Lymphaticovenous Micro-Anastomosis in people with Lymphedema and Post Mastectomy, run by University of Arkansas at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Lymphedema, Post Mastectomy
What is being tested?: Lymphaticovenous Micro-Anastomosis
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Jul 2017
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is 18-70 years of age
Subject is Stage II-IV unilateral lymphedema

Who cannot join

Subject is less than 6 months from completion of cancer treatment
Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
Subject is medically unfit for the procedure
Subject is unable to complete the follow-up visits
Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
Subject has bilateral lymphedema

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

Conditions: Lymphedema, Post Mastectomy
Being tested: Lymphaticovenous Micro-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 Micro-AnastomosisProcedure or surgery

Study groups in NCT02020837
Study group	Role	What they receive
Lymphaticovenous Micro-Anastomosis	Experimental	Not described Receives: Procedure: Lymphaticovenous Micro-Anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.
Measured: 3 and 6 months from surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jul 2017

First posted25 Dec 2013 (estimated)
Study startSep 2014
Primary completion3 Dec 2015
Study completionJul 2017

Why it stopped: Halted prematurely due to low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphedemaStudies of the same condition, open and under way.
More trials run by University of ArkansasThe 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02020837
Sponsor's protocol ID: 202676
Status last verified: Apr 2018
First submitted: 19 Dec 2013
Last updated: 27 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
ClinicalTrials.gov ID: NCT02020837
Acronym / sponsor ID: 202676
Conditions: Lymphedema, Post Mastectomy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Halted prematurely due to low enrollment
Enrolment: 2 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Study start: Sep 2014
Primary completion: 3 Dec 2015 (actual)
Study completion: Jul 2017 (actual)
First posted: 25 Dec 2013 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A lymphatic diversion with lymphaticovenous microanastomosis will be performed.

Arm	Type	Receives
Lymphaticovenous Micro-Anastomosis	Experimental	Procedure: Lymphaticovenous Micro-Anastomosis

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject is 18-70 years of age
Subject is Stage II-IV unilateral lymphedema

Key exclusion criteria (6 listed)

Subject is less than 6 months from completion of cancer treatment
Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
Subject is medically unfit for the procedure
Subject is unable to complete the follow-up visits
Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.

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 Micro-Anastomosis	Procedure or surgery	Lymphaticovenous Micro-Anastomosis

Primary outcome

Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Time frame: 3 and 6 months from surgery
Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lymphaticovenous Micro-Anastomosis	2	2

Primary outcome: Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery

Time frame: 3 and 6 months from surgery

Population analysed: Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lymphaticovenous Micro-Anastomosis	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lymphedema

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

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.

Mauricio Moreno, MD principal investigator

University of Arkansas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Lymphaticovenous Micro-Anastomosis in people with Lymphedema and Post Mastectomy, run by University of Arkansas at 1 site in United States.

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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Jun 2018. 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 United States. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery (time frame: 3 and 6 months from surgery). 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 NCT02020837.

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 27 Jun 2018.