NCT06290232: FLUMEN

Fetoscopic Laser Photocoagulation in Management of Vasa Previa

Not yet recruiting NA Last updated 26 September 2024

What this trial tests

NA trial testing Fetoscopic Laser Photocoagulation in Vasa Previa in 20 participants. Not yet recruiting.

Timeline

1 December 2024

Primary endpoint
1 August 2027

31 March 2028

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2024
Primary completion	1 August 2027
Estimated completion	31 March 2028
Sites	1 location across United States

Drugs / interventions tested

• Fetoscopic Laser Photocoagulation

Conditions studied

• Vasa Previa — all drugs for Vasa Previa →
• Pregnancy Complications — all drugs for Pregnancy Complications →
• Maternal; Procedure — all drugs for Maternal; Procedure →
• In Utero Procedure Affecting Fetus or Newborn — all drugs for In Utero Procedure Affecting Fetus or Newborn →

Sponsor

Boston Children's Hospital

Who can join

Adults 18 to 55, female only, with Vasa Previa or Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.

Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vasa Previa: Prenatal Diagnosis and the Rationale Behind Using a 5 cm Distance from Internal Os.
   Schenone CV, Aghajani F, Javinani A, Krispin E, et al · · 2025 · cited 3× · PMID 39941678 · DOI 10.3390/jcm14031009
2. Incidence and outcomes of vasa praevia in the United Kingdom.
   Attilakos G, David AL, Tunn R, Knight M, et al · · 2024 · cited 1× · PMID 39355303 · DOI 10.3310/nihropenres.13696.2