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RECRUITING NA

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

NCT06056635 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DEVICE Karl Storz Curved Scope
  • DEVICE Karl Storz Straight Scope

Study Locations (1)

Massachusetts

  • Boston Children's Hospital — Boston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-08-15
Est. Completion 2027-05-01
Phase NA

Sponsor

Boston Children's Hospital

752 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06056635

The ClinicalTrials.gov registry entry for NCT06056635 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 752 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions — of which Karl Storz Curved Scope is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06056635 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06056635 about?

NCT06056635 is a clinical study titled "A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures". 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 cu...

What is the current status of trial NCT06056635?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-08-15. Estimated completion is 2027-05-01.

What conditions does trial NCT06056635 study?

This clinical trial studies the following conditions: Pregnancy Related, Twin to Twin Transfusion Syndrome, Twin Reversal Arterial Perfusion Syndrome, Twin Monochorionic Monoamniotic Placenta, In Utero Procedure Affecting Fetus or Newborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06056635?

The interventions under investigation include: Karl Storz Curved Scope (DEVICE), Karl Storz Straight Scope (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06056635?

This trial is sponsored by Boston Children's Hospital, which has 752 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06056635 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial