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?

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.

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.

How does the treatment using Karl Storz Curved and Straight Scopes for in-utero procedures differ from other treatments?

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 potentially treating fetal conditions. This minimally invasive approach, guided by ultrasound, reduces risks compared to more invasive procedures and is particularly useful in high genetic risk pregnancies. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Karl Storz Curved Scope, Karl Storz Straight Scope, Karl Storz Straight Fetoscope, 11506AAK?

The research shows that the STORZ video laryngoscope, which is similar to the Karl Storz scopes, is effective in managing difficult airways in infants by providing a better view during procedures. This suggests that the Karl Storz scopes used in the trial may also be effective in improving visibility and access during in-utero procedures. ^{6 7 8 9 10}

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.

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

I am cleared to undergo procedures that require anesthesia.

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

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]

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 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]

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]

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]

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, 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]

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]

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]

Citations

1. France 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. [2022]

2. England 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. [2019]

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

Airway scope and StyletScope for tracheal intubation in a simulated difficult airway. [2008]

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

Management of the difficult infant airway with the Storz Video Laryngoscope: a case series. [2022]

5. France pubmed.ncbi.nlm.nih.gov

A comparison of bonfils fiberscope-assisted laryngoscopy and standard direct laryngoscopy in simulated difficult pediatric intubation: a manikin study. [2010]

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

The "fetoscope"--a new clinical tool for prenatal genetic diagnosis. [2019]

7. India pubmed.ncbi.nlm.nih.gov

The art of fetoscopy: a step toward minimally invasive fetal therapy. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

[Fetoscopy (author's transl)]. [2007]