In Utero Procedure Affecting Fetus or NewbornNCT06425471
The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
A study testing KARL STORZ fetoscope arm in people with In Utero Procedure Affecting Fetus or Newborn, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- In Utero Procedure Affecting Fetus or Newborn
- What is being tested?
- KARL STORZ fetoscope arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman
- The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
- Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure
Who cannot join
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
- Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation
- Suspicion of a major recognized syndrome by ultrasound or MRI
- Maternal BMI >40 kg/m2
- High risk for fetal hemophilia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas health Science Center at Houston
Houston, Texas, 77030
Jimmy Espinoza, MD, MSc,FACOG, (713) 500-5859, Jimmy.Espinoza@uth.tmc.edu
Elisa Garcia, 713-500-6347, Elisa.I.Garcia@uth.tmc.edu
About this study
Official title: A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
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
Read the detailed description
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
- Being tested
- KARL STORZ fetoscope arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KARL STORZ fetoscope armDevice
The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)
| Study group | Role | What they receive |
|---|---|---|
| KARL STORZ fetoscope arm | Experimental | Not described Receives: Device: KARL STORZ fetoscope arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery in patients requiring percutaneous in-utero surgery
Measured: at time of delivery (about 10 weeks after in utero surgery)
Secondary outcomes (11)
Number of successful procedures with completion of laser ablation of the abnormal vessels.
Measured: within 24 hours of in utero surgery
Improved visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes.
Measured: within 24 hours of in utero surgery
Improved angle for laser visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Measured: within 24 hours of in utero surgery
Improved ease of use of the new fetoscope as assessed by a questionnaire
This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome
Measured: within 24 hours of in utero surgery
Operative time in minutes
Time from from operative cannula insertion until it is removed
Measured: end of surgery ( about 1 hour form start of surgery)
Number of fetuses alive prior to hospital discharge
Measured: time of discharge (about 48 hours after surgery)
Total number of maternal patients that present with short term morbidity
Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption
Measured: from end of surgery to within 10 weeks after surgery
Total number of patients that have maternal and/or fetal perioperative complications
Measured: from end of surgery to within 10 weeks after surgery
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Measured: from end of surgery to within 10 weeks after surgery
Total number of live births
Measured: from time of in utero surgery till delivery (about 10 weeks after surgery)
Total number of short-term morbidities
Short-term morbidities include, but are not limited to, premature delivery (<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis.
Measured: from time of in utero surgery till delivery (about 10 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start4 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Utero Procedure Affecting Fetus or NewbornStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Espinoza, The University of Texas Health Science Center, Houston
- Investigators
- Jimmy Espinoza, MD, MSc,FACOG, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425471
- Sponsor's protocol ID
- HSC-MS-22-1019
- Status last verified
- Aug 2025
- First submitted
- 17 May 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
- ClinicalTrials.gov ID
- NCT06425471
- Acronym / sponsor ID
- HSC-MS-22-1019
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KARL STORZ fetoscope arm | Experimental | Device: KARL STORZ fetoscope arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant woman
- The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
- Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure
Key exclusion criteria (7 listed)
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
- Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation
- Suspicion of a major recognized syndrome by ultrasound or MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KARL STORZ fetoscope armThe type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS) | Device | KARL STORZ fetoscope arm |
Primary outcome
Gestational age at delivery in patients requiring percutaneous in-utero surgery
Time frame: at time of delivery (about 10 weeks after in utero surgery)
11 secondary outcomes
Number of successful procedures with completion of laser ablation of the abnormal vessels.
Time frame: within 24 hours of in utero surgery
Improved visualization as assessed by the Likert scale
Time frame: within 24 hours of in utero surgery
Improved angle for laser visualization as assessed by the Likert scale
Time frame: within 24 hours of in utero surgery
Improved ease of use of the new fetoscope as assessed by a questionnaire
Time frame: within 24 hours of in utero surgery
Operative time in minutes
Time frame: end of surgery ( about 1 hour form start of surgery)
Number of fetuses alive prior to hospital discharge
Time frame: time of discharge (about 48 hours after surgery)
Total number of maternal patients that present with short term morbidity
Time frame: from end of surgery to within 10 weeks after surgery
Total number of patients that have maternal and/or fetal perioperative complications
Time frame: from end of surgery to within 10 weeks after surgery
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Time frame: from end of surgery to within 10 weeks after surgery
Total number of live births
Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)
Total number of short-term morbidities
Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for In Utero Procedure Affecting Fetus or Newborn
Enrolling by invitation
Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
In Utero Procedure Affecting Fetus or Newborn
Recruiting
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Fetal Conditions, Maternal; Procedure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jimmy Espinoza, MD, MSc,FACOG principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KARL STORZ fetoscope arm in people with In Utero Procedure Affecting Fetus or Newborn, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jimmy Espinoza, MD, MSc,FACOG ((713) 500-5859, Jimmy.Espinoza@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery in patients requiring percutaneous in-utero surgery (time frame: at time of delivery (about 10 weeks after in utero surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.