New Fetoscopes for Fetal Disorders

Overseen By Jainnee Sacksith

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Age <18, Preterm labor, Preeclampsia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and feasibility of performing surgery on babies before birth using new fetoscopes, which are special tools for in-womb surgery. The goal is to determine if these improved tools can treat certain fetal conditions while still in the womb. Pregnant women who are healthy enough for surgery and have planned surgical procedures may be suitable candidates for this study. Participants must understand and agree to the risks involved in these procedures.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance fetal surgery techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these new fetoscopes are safe for fetal surgery?

Researchers are conducting studies to ensure the safety of the Karl Storz New Generation Fetoscope, a tool for surgeries on babies still in the womb. These fetoscopes help doctors see and reach the fetus more easily. Although new and not yet FDA-approved, researchers aim to confirm their safety and effectiveness.

Currently, specific safety data from these studies is unavailable. However, since the trial focuses on testing the safety and practicality of the fetoscopes, gathering detailed safety information remains a top priority. As researchers test the fetoscopes for safety, potential participants can be assured that the study will address any safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Karl Storz New Generation Fetoscope is unique because it offers a cutting-edge approach to fetal surgery by allowing precise in utero procedures for conditions that can be treated with fetoscopy. Unlike traditional methods that may rely on more invasive surgeries, this fetoscope is designed to minimize invasiveness while increasing surgical accuracy. Researchers are excited about this treatment because it has the potential to improve outcomes for both the fetus and the mother by reducing risks associated with more invasive surgical procedures.

What evidence suggests that the Karl Storz fetoscopes are effective for fetal disorders?

Research shows that the Karl Storz New Generation Fetoscope improves the accuracy of surgeries on babies while still in the womb. This tool lets doctors see and reach the baby directly inside the mother's body. Previous studies have shown that it helps diagnose and treat conditions in unborn babies. The new features of the fetoscope aim to improve surgery results by giving doctors a clearer view and better access. In this trial, participants will undergo in utero surgery using the new generation Karl Storz fetoscopes to assess its safety and practicality. The device looks promising because of its improved design compared to older models. ^{1 2 3 4 5}

Who Is on the Research Team?

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for pregnant individuals whose babies have been diagnosed with conditions that could potentially be treated through surgery before birth. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and the fetus must be at a stage where in utero surgery is possible.

Inclusion Criteria

The mother must be scheduled for surgery

Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure

I am a pregnant woman aged 18 or older.

Exclusion Criteria

I cannot undergo abdominal or fetoscopic surgery, or be put under general anesthesia.

I have had preterm labor, preeclampsia, or a large fibroid tumor in my current pregnancy.

My unborn baby has been diagnosed with a significant genetic issue or major anomaly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo in utero surgery using the new generation Karl Storz fetoscopes for fetal conditions amenable to treatment with fetoscopy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the in utero surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Karl Storz New Generation Fetoscope

Trial Overview The study is testing new types of fetoscopes by Karl Storz - one curved (11508AAK) and one straight (11506AAK). These tools are designed for surgeries on the baby while still in the womb. The goal is to assess how feasible and safe these procedures are using the new instruments.

How Is the Trial Designed?

Group I: Karl Storz fetoscopes Experimental Treatment 2 Interventions

Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The use of fetoscopy under local anesthesia in 23 pregnant women (13-20 weeks) significantly reduced the risk of fetal damage during procedures like planned surgical abortion.

Fetoscopy allowed for better visualization of fetal structures and successful attempts to obtain fetal blood, indicating its potential for routine use in diagnosing congenital anomalies, although further experience is needed to confirm its safety and simplicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fetoscopy under ultrasound control (author's transl)]. Rauskolb, R.[2006]

Fetoscopy, performed on 12 women between 12-20 weeks of gestation, is a feasible and safe procedure for examining fetal congenital malformations, with no major complications reported.

The procedure requires significant skill and has a learning curve, but improved visualization was achieved using a 2-mm diameter endoscope, allowing for advanced techniques like laser coagulation in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The art of fetoscopy: a step toward minimally invasive fetal therapy. Deka, D., Dadhwal, V., Gajatheepan, SB., et al.[2021]

Fetoscopy using a small-diameter instrument was successfully performed in 23 out of 26 fetuses, allowing for direct visualization of the fetus, which is crucial for diagnosing potential issues during pregnancy.

The procedure is relatively safe and uncomplicated, with a success rate of approximately 39% for total visualization of the fetus, making it a valuable tool for high-risk pregnancies, particularly for genetic assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience with fetoscopy (author's transl)]. Rauskolb, R.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06281730?term=AREA%5BConditionSearch%5D(Uterus%20disorders)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2018-12-27,MAX%5D&rank=9

Use of New Generation Fetoscopes in Pregnancies ... The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20577079

Clinical Trials The purpose of this study is to determine feasibility and safety of performing in utero surgery with the Karl Storz fetoscopes (11508AAK and 11506AAK).

3. withpower.com withpower.com/trial/phase-fetal-diseases-1-2024-ceab6

New Fetoscopes for Fetal Disorders · Info for Participants The Karl Storz New Generation Fetoscope is unique because it allows direct visualization and access to the fetus in the womb, enabling precise diagnosis and ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06056635/a-prospective-study-on-the-role-of-karl-storz-curved-and-straight-fetoscopes-11508aak-and-11506aak-for-fetoscopic-intrauterine-procedures

A Prospective Study on the Role of Karl Storz Curved and ... The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery.

5. ctv.veeva.com ctv.veeva.com/study/a-prospective-study-on-the-efficacy-of-the-karl-storz-curved-fetoscope-11508aak-and-its-straight-v

The Use of Karl Storz Curved Fetoscope (11508aak) and Its ... Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes.