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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Karl Storz New Generation Fetoscope for fetal disorders?

Research shows that using a fetoscope for procedures like laser treatment in twin-to-twin transfusion syndrome can be safe and effective, improving outcomes by allowing precise surgical interventions with minimal risk. ^{1 2 3 4 5}

How does the Karl Storz New Generation Fetoscope treatment differ from other treatments for fetal disorders?

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 potential treatment of fetal disorders. Unlike traditional methods like amniocentesis, which rely on indirect sampling, this fetoscope provides real-time, direct information and can be used for interventions such as fetal blood sampling and surgery. ^{2 6 7 8 9}

What is the purpose of this trial?

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 in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.

Research Team

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

The art of fetoscopy: a step toward minimally invasive fetal therapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sono-endoscopic delineation of the placental vascular equator prior to selective fetoscopic laser ablation in twin-to-twin transfusion syndrome. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

From a Disposable Ureteroscope to an Active Lightweight Fetoscope-Characterization and Usability Evaluation. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Neonatal outcome using ultrathin fetoscope for laser coagulation in twin-to-twin-transfusion syndrome. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

First trimester prenatal diagnosis: embryoscopy and fetoscopy. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Development of a fetoscope and its clinical application]. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Prenatal diagnosis of hemoglobinopathies in twin pregnancies by double simultaneous fetoscopy. [2019]