Curved vs Straight Fetoscope for In-Utero Surgery

Overseen By Elisa Garcia

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Preterm labor, Preeclampsia, Uterine anomaly, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of fetoscopes, curved and straight, to determine which is more effective for in-utero surgeries. These surgeries typically treat certain conditions affecting the baby before birth. The trial is best suited for pregnant women who require this type of surgery and have consented to participate. Participants should not have conditions that complicate surgery, such as preterm labor or certain genetic issues. As an unphased trial, it offers participants the opportunity to contribute to advancements in prenatal surgical techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that these fetoscopes are safe for in-utero surgery?

Research has shown that using the KARL STORZ curved and straight fetoscopes for fetal surgery is generally safe. Studies have assessed the practicality and safety of these tools for accessing the baby, with no major problems reported, indicating that the procedure is well-tolerated.

The success rate for fully visualizing the baby during surgery is about 39%, demonstrating the effectiveness of these fetoscopes. They have been used in conditions like Twin-to-Twin Transfusion Syndrome (TTTS) and other fetal issues, with no significant complications reported.

Although detailed safety data remains limited, the ongoing use and testing of these fetoscopes suggest they are reasonably safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of curved versus straight fetoscopes for in-utero surgery because these tools may offer enhanced precision and flexibility during delicate fetal procedures. Unlike traditional straight fetoscopes, the curved version is designed to navigate better around the challenging contours of the womb, potentially reducing the risk of injury to both the mother and fetus. This innovation could lead to improved surgical outcomes by allowing surgeons to access hard-to-reach areas with greater ease and accuracy, ultimately advancing the field of fetal surgery.

What evidence suggests that these fetoscopes are effective for in-utero surgery?

This trial will compare the KARL STORZ Curved Fetoscope with the KARL STORZ Straight Fetoscope for in-utero surgery. Research has shown that the KARL STORZ Curved Fetoscope enhances visibility of the front of the placenta due to its shape, which is crucial for procedures involving this area. Studies indicate that doctors can fully see the fetus about 39% of the time during surgery with this device, making it quite useful. Both the curved and straight versions are designed to provide a clear view of the fetus inside the womb, aiding in diagnosing and treating conditions during pregnancy. Surgeons have reported satisfaction with these fetoscopes, suggesting they are effective tools for surgery inside the womb. ^{1 2 4 6 7}

Who Is on the Research Team?

Jimmy Espinoza, MD, MSc,FACOG

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for pregnant women who meet the criteria for in-utero surgery based on existing medical guidelines. They must provide informed consent acknowledging the risks to both mother and fetus. Women with a BMI over 40, genetic abnormalities in the fetus, or conditions like preeclampsia are excluded.

Inclusion Criteria

Pregnant woman

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

I meet the requirements for surgery before birth.

Exclusion Criteria

Maternal BMI >40 kg/m2

Suspicion of a major recognized syndrome by ultrasound or MRI

Allergy or previous adverse reaction to a study medication specified in this protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-utero Surgery

Participants undergo in-utero surgery using the KARL STORZ curved or straight fetoscope

1 day

1 visit (in-person)

Immediate Post-operative Assessment

Assessment of visualization and ease of use within 24 hours post-surgery

1 day

Follow-up

Participants are monitored for short-term morbidities and maternal outcomes until delivery

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KARL STORZ Curved Fetoscope (11508AAK)
• KARL STORZ Straight Fetoscope (11506AAK)

Trial Overview The study is comparing two types of fetoscopes by KARL STORZ: a curved model (11508AAK) and a straight one (11506AAK), used during fetal surgery. The goal is to determine which design offers better efficacy for these delicate procedures.

How Is the Trial Designed?

Group I: KARL STORZ fetoscope arm Experimental Treatment 1 Intervention

KARL STORZ Curved Fetoscope (11508AAK) is already approved in United States, European Union for the following indications:

Approved in United States as KARL STORZ Curved Fetoscope (11508AAK) for:

• In-utero surgery for conditions such as twin-twin transfusion syndrome (TTTS), twin anemia polycythemia sequence (TAPS), selective fetal growth restriction (sFGR), twin reversed arterial perfusion (TRAP) sequence, chorioangioma, vasa previa, and other complex congenital anomalies

Approved in European Union as KARL STORZ Curved Fetoscope (11508AAK) for:

• In-utero surgery for conditions such as twin-twin transfusion syndrome (TTTS), twin anemia polycythemia sequence (TAPS), selective fetal growth restriction (sFGR), twin reversed arterial perfusion (TRAP) sequence, chorioangioma, vasa previa, and other complex congenital anomalies

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

The double-spring pre-curved cannula (DSPC) was developed to enhance surgical access with a small diameter of 3.9 mm and high stiffness, allowing for effective electrocauterization in hard-to-reach areas.

In cadaveric studies, the DSPC successfully accessed the inferior glenohumeral ligament, demonstrating its potential to outperform conventional surgical instruments in specific surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel arthroscopic pre-curved cannula with both flexibility and high stiffness. Park, C., Kim, J., Moon, Y., et al.[2022]

In a study of 176 monochorionic twin pregnancies undergoing fetoscopic laser coagulation (FLC) for severe twin-to-twin transfusion syndrome (TTTS), the use of a 30 degrees fetoscope in challenging anterior placentation resulted in similar outcomes to the standard 0 degrees fetoscope used in more favorable placental locations.

Both groups had comparable survival rates for the fetuses, with 58.8% of study patients having both fetuses survive compared to 66.4% in the control group, indicating that the 30 degrees fetoscope is an effective alternative in difficult cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser coagulation of placental anastomoses with a 30 degrees fetoscope in severe mid-trimester twin-twin transfusion syndrome with anterior placenta. Huber, A., Baschat, AA., Bregenzer, T., et al.[2008]

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]

The study compared the performance of various flexible and rigid endoscopes used in kidney procedures, focusing on irrigant flow rates and visual characteristics.

Understanding the differences in flow rates and visual angles of these instruments is crucial for selecting the appropriate tool for effective endourologic procedures like stone removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical characteristics of percutaneous nephroscopes. Khasidy, LR., Ansong, K., Smith, AD.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06084247

The Efficacy of the KARL STORZ Curved Fetoscope and ... The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.

2. 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.

3. withpower.com withpower.com/trial/curved-vs-straight-fetoscope-for-in-utero-surgery-5383a

Curved vs Straight Fetoscope for In-Utero Surgery 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 ...

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. clinconnect.io clinconnect.io/trials/NCT06425471

The Use of Karl Storz Curved Fetoscope (11508aak) and The main goal is to see how effective the curved version and the straight version of the Karl Storz fetoscope are for performing these in-utero surgeries. This ...

6. 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 ...

7. withpower.com withpower.com/trial/fetoscopes-for-in-utero-procedures-7e124

Fetoscopes for In-Utero Procedures Participants undergo fetoscopic intrauterine procedures using Karl Storz Curved and Straight Fetoscopes for conditions like TTTS, TAPS, sFGR, or TRAP sequence.