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Procedure

Karl Storz fetoscopes for In Utero Procedure

N/A

Recruiting

Led By Mauro Schenone, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is a pregnant woman 18 and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether it is safe and possible to perform surgery on a baby in the womb using new and improved Karl Storz fetoscopes, which are tools to access the baby inside the mother

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't listed, but generally, fetal surgery can carry risks such as preterm labor, rupture of membranes, or complications related to anesthesia. There may also be specific risks associated with using these new fetoscopes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a pregnant woman aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Device malfunctions

Serious Adverse Events

Secondary outcome measures

Live births

Mean gestational age at delivery

Neonatal deaths

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Karl Storz fetoscopesExperimental Treatment2 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,911 Total Patients Enrolled

Mauro Schenone, M.D.Principal InvestigatorMayo Clinic

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 slots for patients to participate in this research study?

"Affirmative. Details on clinicaltrials.gov confirm that this trial is currently in the recruitment phase. The initial posting date was 2/1/2024, and the most recent update occurred on 2/21/2024. Recruitment aims to enroll 100 patients at a single site."

Answered by AI

What is the current number of individuals actively engaged in this clinical investigation?

"Yes, the information available on clinicaltrials.gov indicates that this research study is actively seeking participants. It was first posted on February 1st, 2024 and last updated on February 21st, 2024. The trial aims to recruit a total of 100 individuals from one location."

Answered by AI

What are the primary goals of this experiment?

"This clinical trial, spanning about 12 months, aims to primarily assess adverse events. Secondary goals involve tracking neonatal deaths (defined as the number of subjects experiencing this outcome post in-utero surgery), live births (defined as the count of subjects delivering a living baby after in-utero surgery), and mean gestational age at delivery (measured in weeks)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy

Mauro H. Schenone 2024. "Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06281730.

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