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NCT06056635 · ClinicalTrials.gov registry record · NA
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
A NA study of Pregnancy Related and Twin to Twin Transfusion Syndrome, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06056635 is a NA study of Pregnancy Related and Twin to Twin Transfusion Syndrome that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 50 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06056635, a NA study of Pregnancy Related and Twin to Twin Transfusion Syndrome, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DEVICE Karl Storz Curved Scope
- DEVICE Karl Storz Straight Scope
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2027-05-01 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
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.
NCT06056635 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
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.
What interventions are being tested in trial NCT06056635?
The interventions under investigation include: Karl Storz Curved Scope (DEVICE), Karl Storz Straight Scope (DEVICE).
Who is sponsoring clinical trial NCT06056635?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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.
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