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Nerve Repair with Polyethylene Glycol for Gender Dysphoria
Phase 2 & 3
Waitlist Available
Led By Wesley Thayer, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial aims to improve neophallus sensation after phalloplasty for transmasculine patients by fusing severed nerves with a topical solution.
Who is the study for?
This trial is for adults over 18 with gender dysphoria who are undergoing phalloplasty using tissue from their forearm. They must be willing to follow treatment and study evaluations for up to 15 months post-surgery. It's not for those allergic to PEG, with high hematocrit levels, or a history of blood clots, vein inflammation, recent stroke or heart attack.Check my eligibility
What is being tested?
The trial tests if applying polyethylene glycol (PEG) during phalloplasty can improve sensation in the newly constructed neophallus. The goal is to see if PEG helps nerves heal better after surgery, potentially enhancing quality of life.See study design
What are the potential side effects?
Specific side effects aren't listed here but may include reactions at the site where PEG is applied. Since participants have conditions excluding them based on allergies to PEG and certain cardiovascular risks, these factors could indicate potential areas of concern.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medical Research Council Classification (MRCC)
Secondary outcome measures
Sexual Functioning and Sensation Questionnaire
Vanderbilt Mini-PROM for Gender-Affirming Surgery(VMP-G)
Side effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605126%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
For the experimental group, after obtaining hemostasis, prior to neurorrhaphy, the operative field will be irrigated with calcium-free Plasmalyte A® (Baxter: Deerfield, IL) throughout the neurorrhaphy. At this point, the nerves will be repaired using standard suture neurorrhaphy techniques. Subsequently, approximately 1 or 2 drops of 5mg/ml (0.5%) methylene blue in sterile water solution are applied to the trimmed nerve endings. Then, approximately 2 ccs of a 190 mM solution of 50% PEG 3.35 kD in sterile water will be irrigated onto the neurorrhaphy site and the surgeon will wait one minute prior to continuing. Following this, the repaired nerve will be irrigated with calcium-containing Lactated Ringers (Hospira; Lake Forest, IL).
Group II: Control (No Intervention)Active Control1 Intervention
For the control groups, epineural repair will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene Glycol 3350
2023
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,162 Total Patients Enrolled
Wesley Thayer, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a blood clot, stroke, or heart attack in the last 6 months.I am diagnosed with gender dysphoria and planning to undergo forearm flap surgery for phalloplasty.I am over 18 years old.I am willing to follow all treatment and study check-up plans.
Research Study Groups:
This trial has the following groups:- Group 1: Control (No Intervention)
- Group 2: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals is the medical research recruiting for participation?
"Affirmative, as per the data on clinicaltrials.gov, this medical investigation is actively looking for test subjects. It was originally declared open to recruitment on June 3rd 2023 and recently updated on June 1st 2023; they are seeking 30 participants from a single site."
Answered by AI
Are participants being recruited for this investigation currently?
"As attested on clinicaltrials.gov, this medical trial remains open for applicants since its original posting date of June 3rd 2023 and most recent edit occurring on the 1st of June 2023."
Answered by AI
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