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Procedure

Fetoscopic Laser Photocoagulation Surgery for Vasa Previa (FLUMEN Trial)

N/A
Waitlist Available
Led By Alireza Shamshirsaz
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when the last (20th) participant undergoes flp surgery, about 3 years from study start date.
Awards & highlights

FLUMEN Trial Summary

This trial aims to study the safety and effectiveness of a fetal surgery called fetoscopic laser photocoagulation (FLP) for the treatment of vasa previa (VP), a dangerous pregnancy complication

Who is the study for?
This trial is for pregnant individuals diagnosed with vasa previa, a condition where fetal blood vessels cover the womb's entrance. Participants should be in their third trimester and have not undergone any prior treatment for vasa previa. Specific inclusion and exclusion criteria details are not provided.Check my eligibility
What is being tested?
The study tests fetoscopic laser photocoagulation (FLP), a minimally invasive surgery aiming to correct abnormal fetal blood vessels in pregnancies complicated by vasa previa. The goal is to reduce severe bleeding risks, potentially avoid long hospital stays before delivery, and enable vaginal birth.See study design
What are the potential side effects?
Potential side effects of FLP may include complications from surgery such as bleeding or infection, adverse reactions affecting the mother or fetus due to the procedure itself, but exact side effects are not detailed in this summary.

FLUMEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when the last (20th) participant undergoes flp surgery, about 3 years from study start date.
This trial's timeline: 3 weeks for screening, Varies for treatment, and when the last (20th) participant undergoes flp surgery, about 3 years from study start date. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gestational age at delivery
Mode of delivery
Placental function
+4 more
Secondary outcome measures
Cause for hospital admission
Duration of hospital stay
Fetal brain structure
+14 more

FLUMEN Trial Design

1Treatment groups
Experimental Treatment
Group I: Fetoscopic Laser Photocoagulation SurgeryExperimental Treatment1 Intervention
Pregnant individuals diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
764 Previous Clinical Trials
5,580,659 Total Patients Enrolled
1 Trials studying Vasa Previa
50 Patients Enrolled for Vasa Previa
Alireza ShamshirsazPrincipal InvestigatorDirector, Maternal Fetal Care Center
Alireza Shamshirsaz, MDPrincipal InvestigatorDirector, Maternal Fetal Care Center; Chief, Division of Fetal Medicine and Surgery
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to details on clinicaltrials.gov, the current trial is not in active recruitment. Although it was first listed on May 1st, 2024 and updated lastly on February 26th, 2024. Despite this trial being closed for enrollment currently, there are numerous other trials actively seeking participants - totaling at least 58 studies presently open for recruitment."

Answered by AI

What are the specific objectives of this research study?

"The primary goal of this study is to evaluate placental function, with data collection planned until the 20th participant undergoes FLP surgery approximately three years from the commencement of the research. Secondary aims encompass monitoring the rate of NICU admissions following birth, documenting reasons for hospital admission before delivery, and recording the duration between FLP procedure and childbirth in weeks and days."

Answered by AI

Are individuals who are above the age of 25 being sought for participation in this study?

"Recruitment for this study is limited to individuals aged over 18 years and under 55 years."

Answered by AI
Recent research and studies
Obstetrics & GynecologyJournal
Acog
“Acog”. 2019. “Acog”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000003018.
American Journal of Respiratory and Critical Care MedicineJournal
The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach
Jensen, Erik A., Kevin Dysart, Marie G. Gantz, Scott McDonald, Nicolas A. Bamat, Martin Keszler, Haresh Kirpalani, et al.. 2019. “The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201812-2348oc.
clinicaltrials.govStudy
Fetoscopic Laser Photocoagulation in Management of Vasa Previa
Alireza Shamshirsaz 2024. "Fetoscopic Laser Photocoagulation in Management of Vasa Previa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290232.
~13 spots leftby May 2027
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