Fetoscopes for In-Utero Procedures

Overseen By Brittany Gudanowski

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston Children's Hospital

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: Unknown

Duration: 3 years

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how new surgical tools called fetoscopes can assist with in-utero surgeries, which are operations performed inside the womb. The fetoscopes, including the Karl Storz Curved Scope and the Karl Storz Straight Scope, function like tiny cameras, enabling doctors to see and address problems with blood vessels in the placenta using laser energy. Pregnant patients requiring in-womb surgery, who can undergo anesthesia and provide consent, might be suitable candidates for this study. The trial will evaluate the effectiveness of these fetoscopes and any potential complications. As an unphased trial, this study offers a unique opportunity for patients to contribute to pioneering research in fetal surgery techniques.

Will I have to stop taking my current medications?

The trial information 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 procedures?

Research has shown that the Karl Storz Curved and Straight Fetoscopes are generally well-tolerated during surgeries inside the womb. These tools enable doctors to see inside the womb for less invasive surgeries. Studies have examined their effectiveness and safety in procedures like fetoscopic laser photocoagulation.

Early results indicate that these devices help doctors accurately identify and treat abnormal blood vessel connections in the placenta. While detailed safety information remains unavailable, their use in delicate surgeries suggests confidence in their safety. Although new, the scopes aim to reduce risk and improve surgical outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Karl Storz Curved and Straight Fetoscopes for in-utero procedures because they offer tailored visualization options based on the placenta's position. Unlike traditional methods, which might not account for the placenta's location, these fetoscopes are specially designed to enhance visibility during procedures. The curved scope is ideal for cases where the placenta is at the front of the uterus, while the straight scope is suited for when the placenta is at the back. This specificity helps improve the precision and safety of diagnostic and interventional procedures performed in the womb.

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

Research shows that the Karl Storz Curved and Straight Fetoscopes effectively facilitate surgery inside the womb. In this trial, participants will use either the Karl Storz Curved or Straight Fetoscope, depending on the placenta's position. These devices enable doctors to see inside during surgery, which is crucial for safely performing procedures like using a laser to seal off abnormal blood vessels in the placenta. Studies have shown that using these fetoscopes can lead to better health outcomes for both mothers and babies. Specifically, improvements in surgical techniques have been linked to better health for both. Additionally, these scopes have a success rate of about 39% for fully visualizing the fetus, making them valuable for surgeries on unborn babies. This suggests they are promising tools for diagnosing and managing conditions in the womb during pregnancy. ^{1 3 5 6 7}

Who Is on the Research Team?

Eyal Krispin, MD

Principal Investigator

Fetal Surgeon

Are You a Good Fit for This Trial?

This trial is for pregnant individuals needing in-utero surgery due to conditions like Twin Reversal Arterial Perfusion Syndrome or Twin to Twin Transfusion Syndrome. Participants must be able to undergo anesthesia and provide informed consent, along with the fetus's father if possible.

Inclusion Criteria

I am pregnant and need surgery for my baby before birth.

I am cleared to undergo procedures that require anesthesia.

Patient and father of the fetus (if available) are able to provide signed informed consent

Exclusion Criteria

I have had preterm labor, preeclampsia, or a large fibroid during this pregnancy.

My ultrasound or MRI suggests a severe birth defect that is not survivable after birth.

I cannot have surgery on my abdomen or through a scope.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

3 years

Follow-up

Participants are monitored for surgical outcomes, short and long-term morbidity, complications, and gestational age until birth.

Up to 3 years

Post-birth Follow-up

Neonatal outcomes such as survival and morbidity are assessed 30 days post-birth.

30 days post-birth

What Are the Treatments Tested in This Trial?

Interventions

• Karl Storz Curved Scope
• Karl Storz Straight Scope

Trial Overview The study tests Karl Storz Curved and Straight Fetoscopes during minimally invasive fetal surgeries. The curved scope is for anterior placenta cases, while the straight one is for posterior placenta cases, aiming to improve surgical outcomes.

How Is the Trial Designed?

Group I: Karl Storz Curved or Straight Scope Experimental Treatment 2 Interventions

A Karl Storz Curved (11508AAK) or Straight (11506AAK) Fetoscope will be used to provide visualization during in-utero (in the womb) diagnostic and interventional procedures. The curved scope will be used in patients with a placenta that sits at the front of their uterus. The straight scope will be used in patients with a placenta that sits at the back of their uterus.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Fetoscopy, performed on 12 women between 12-20 weeks of gestation, is a feasible and safe procedure for examining fetal congenital malformations, with no major complications reported.

The procedure requires significant skill and has a learning curve, but improved visualization was achieved using a 2-mm diameter endoscope, allowing for advanced techniques like laser coagulation in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The art of fetoscopy: a step toward minimally invasive fetal therapy. Deka, D., Dadhwal, V., Gajatheepan, SB., et al.[2021]

In a study involving 10 pediatric anesthesiologists performing 150 intubations on a simulated difficult infant airway, the Bonfils fiberscope provided a better view of the larynx compared to standard direct laryngoscopy, achieving a 100% visibility score in difficult airway scenarios.

While the Bonfils fiberscope did not improve the intubation success rate (98% vs. 90% for direct laryngoscopy in difficult scenarios) or reduce the time to intubate, it was easier to use, suggesting it may be a valuable adjunct in challenging pediatric airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of bonfils fiberscope-assisted laryngoscopy and standard direct laryngoscopy in simulated difficult pediatric intubation: a manikin study. Vlatten, A., Aucoin, S., Litz, S., et al.[2010]

The STORZ DCI video laryngoscope offers a significantly better view of the glottis compared to standard direct laryngoscopy, achieving a POGO score of 100% versus 97.5%.

However, the use of the video laryngoscope resulted in a longer time to intubate, with a median time of 27 seconds compared to 21 seconds for direct laryngoscopy, indicating a trade-off between visibility and speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the STORZ video laryngoscope and standard direct laryngoscopy for intubation in the Pediatric airway--a randomized clinical trial. Vlatten, A., Aucoin, S., Litz, S., et al.[2022]

The Miller 1 Storz Video Laryngoscope was successfully used in seven infants who experienced difficult intubations, showcasing its effectiveness in challenging cases.

The use of video technology in laryngoscopes offers a valuable alternative for managing difficult intubations, potentially improving safety and success rates in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of the difficult infant airway with the Storz Video Laryngoscope: a case series. Hackell, RS., Held, LD., Stricker, PA., et al.[2022]

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]

Fetoscopy is a minimally invasive procedure that allows for the examination of fetal malformations without chromosomal damage, and it can be performed safely under local anesthesia, with risks comparable to those of standard amniocentesis.

The procedure is primarily indicated when there is a significant risk of serious fetal malformations that may warrant therapeutic abortion, and it requires collaboration with geneticists to assess risks and benefits appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fetoscopy (author's transl)]. Rauskolb, R., Fuhrmann, W.[2007]

In simulated difficult laryngoscopy scenarios, the Pentax Airwayscope (AWS) and Glidescope laryngoscopes outperformed the traditional Macintosh laryngoscope, showing better glottis visibility and higher success rates for tracheal intubation.

The Pentax AWS was particularly effective, requiring less time for intubation, causing less dental trauma, and being rated easier to use by experienced anaesthetists compared to the Macintosh laryngoscope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Glidescope, the Pentax AWS, and the Truview EVO2 with the Macintosh laryngoscope in experienced anaesthetists: a manikin study. Malik, MA., O'Donoghue, C., Carney, J., et al.[2019]

In a study involving 65 patients, the use of a fetoscope with local anesthesia during saline abortion allowed for improved visualization of intrauterine contents, particularly optimal between 16 to 18 weeks of gestation, and was better than photographic records.

No significant complications were reported during the procedure, but caution is advised in high-risk pregnancies until the safety and visualization limitations of fetoscopy are fully addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "fetoscope"--a new clinical tool for prenatal genetic diagnosis. Benzie, RJ., Doran, TA.[2019]

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 involving 100 adult patients with simulated difficult airways due to cervical collars, both the Airway Scope and StyletScope achieved high intubation success rates (98% and 96%, respectively).

The Airway Scope was significantly faster for intubation, taking an average of 32 seconds compared to 51 seconds for the StyletScope, and it had a lower incidence of esophageal intubation, which occurred only with the StyletScope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway scope and StyletScope for tracheal intubation in a simulated difficult airway. Komatsu, R., Kamata, K., Hamada, K., et al.[2008]

Citations

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

The Efficacy of the KARL STORZ Curved Fetoscope and ... The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation ...

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. trialx.com trialx.com/clinical-trials/listings/301725/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 ... Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery ...

4. 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 ...

5. 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 ...

6. 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.

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

Fetoscopes for In-Utero Procedures The Karl Storz Curved and Straight Scopes are unique because they allow direct visualization of the fetus inside the womb, which can help in diagnosing and ...