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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

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.

How does the treatment using curved and straight fetoscopes differ from other treatments for in-utero surgery?

The use of curved and straight fetoscopes in in-utero surgery is unique because it allows for direct visualization of the fetus through a small incision, which can be less invasive and lower risk compared to other surgical methods. The curved fetoscope, in particular, may offer expanded workspace and flexibility, potentially improving access and visualization during the procedure. ^{1 2 3 4 5}

Research Team

Jimmy Espinoza, MD, MSc,FACOG

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

I have complications like preterm labor, high blood pressure during pregnancy, or a large fibroid that could affect surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2008]

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

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

4. England pubmed.ncbi.nlm.nih.gov

A novel arthroscopic pre-curved cannula with both flexibility and high stiffness. [2022]

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

Physical characteristics of percutaneous nephroscopes. [2019]