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A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

ConditionsFetal ConditionsMaternal; ProcedurePregnancy RelatedTwin to Twin Transfusion SyndromeIn Utero Procedure Affecting Fetus or NewbornChorion; AbnormalTwin Reversal Arterial Perfusion SyndromeTwin Monochorionic Monoamniotic PlacentaChorioangiomaVasa Previa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBoston Children's Hospital

About this trial

In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant patient with a condition requiring in-utero surgery

Patient must be eligible for anesthesia

Patient and father of the fetus (if available) are able to provide signed informed consent

Disqualifiers

Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative

Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy

Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life

Pre-pregnancy maternal BMI greater than 40

Trial design

Design model

Single group

Treatments tested in this trial

  • Karl Storz Curved Scope

    Device

    The curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

  • Karl Storz Straight Scope

    Device

    The straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Karl Storz Curved or Straight ScopeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Rate of completed fetoscopic procedures

The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.

Time frame
3 years from study start date
2

Fetal survival at birth

The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.

Time frame
When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.

Secondary outcomes

1

Successful visualization of all targeted vessels

The rate of procedures with these fetoscopes in which there is successful visualization of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.

Time frame
3 years from study start date
2

Successful coagulation of all targeted vessels

The rate of procedures with these fetoscopes in which there is successful coagulation of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.

Time frame
3 years from study start date
3

The rate of preterm labor

The rate of preterm labor following a procedure using these fetoscopes will be analyzed.

Time frame
When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
4

The rate of preterm premature rupture of membranes (PPROM)

The rate of PPROM following a procedure using these fetoscopes will be analyzed.

Time frame
When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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