In Utero Procedure Affecting Fetus or NewbornNCT06281730
Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
A study testing Karl Storz New Generation Fetoscope - curved 11508AAK and Karl Storz New Generation Fetoscope - straight 11506AAK in people with In Utero Procedure Affecting Fetus or Newborn, run by Mayo Clinic at 1 site in United States.
Trial summary
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 in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- In Utero Procedure Affecting Fetus or Newborn
- What is being tested?
- Karl Storz New Generation Fetoscope - curved 11508AAK and Karl Storz New Generation Fetoscope - straight 11506AAK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2024to Feb 2044
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a pregnant woman 18 and older
- The mother must be healthy enough to have surgery
- The mother must be scheduled for surgery
- Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
Who cannot join
- Age <18 years
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
- Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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 in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.
- Being tested
- Karl Storz New Generation Fetoscope - curved 11508AAK, Karl Storz New Generation Fetoscope - straight 11506AAK
- Keywords
- Fetoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karl Storz New Generation Fetoscope - curved 11508AAKDevice
11508AAK Miniature straight forward telescope 0-degree set, curved, diameter 3.3 millimeter, length 30 centimeter, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 French., remote eyepiece, fiber optic light transmission incorporated.
Karl Storz New Generation Fetoscope - straight 11506AAKDevice
11506AAK Miniature straight forward telescope 0-degree, straight, diameter 3.3 millimeter, length 30 cm, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 french, remote eyepiece, fiber optic light transmission incorporated.
| Study group | Role | What they receive |
|---|---|---|
| Karl Storz fetoscopes | Experimental | Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy. Receives: Device: Karl Storz New Generation Fetoscope - curved 11508AAK; Device: Karl Storz New Generation Fetoscope - straight 11506AAK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The count of subjects who experience adverse events
Measured: 12 months
Serious Adverse Events
The count of subjects who experience serious adverse events
Measured: 12 months
Device malfunctions
The number of device malfunction incidents
Measured: 12 months
Secondary outcomes (5)
Mean gestational age at delivery
The mean gestational age at delivery. Measured in weeks.
Measured: 12 months
Successful Completion
The number of successful fetoscopic surgeries in twin twin transfusion syndrome. The measure of success is being able to ablate all anastomoses thought to be involved in causing the twin twin transfusion syndrome.
Measured: 12 months
Satisfaction scores
Surgeon reported satisfaction of the use of the Karl Storz fetoscopes as measured by a 3 item Likert scale questionnaire. The 3 items are scored from 0 - 3, 0 being strongly disagree to 3 being strongly agree. Total scores range from 0 - 9, lower scores indicate less satisfaction, and higher scores indicate more satisfaction.
Measured: 12 months
Live births
The number of subjects to have a live birth following in-utero surgery
Measured: 12 months
Neonatal deaths
The number of subjects who experience a neonate death following in-utero surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Mar 2024
- Primary completionFeb 2044 (estimated)
- Study completionFeb 2044 (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 Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281730
- Sponsor's protocol ID
- 23-009197
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
- ClinicalTrials.gov ID
- NCT06281730
- Acronym / sponsor ID
- 23-009197
- Keywords
- Fetoscopes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- Feb 2044 (estimated)
- Study completion
- Feb 2044 (estimated)
- First posted
- 28 Feb 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 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 in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Karl Storz fetoscopes | Experimental | Device: Karl Storz New Generation Fetoscope - curved 11508AAK, Device: Karl Storz New Generation Fetoscope - straight 11506AAKParticipants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a pregnant woman 18 and older
- The mother must be healthy enough to have surgery
- The mother must be scheduled for surgery
- Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
Key exclusion criteria (4 listed)
- Age <18 years
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
- Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.
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 New Generation Fetoscope - curved 11508AAK11508AAK Miniature straight forward telescope 0-degree set, curved, diameter 3.3 millimeter, length 30 centimeter, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 French., remote eyepiece, fiber optic light transmission incorporated. | Device | Karl Storz fetoscopes |
| Karl Storz New Generation Fetoscope - straight 11506AAK11506AAK Miniature straight forward telescope 0-degree, straight, diameter 3.3 millimeter, length 30 cm, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 french, remote eyepiece, fiber optic light transmission incorporated. | Device | Karl Storz fetoscopes |
Primary outcome
Adverse events
Time frame: 12 months
The count of subjects who experience adverse events
Serious Adverse Events
Time frame: 12 months
The count of subjects who experience serious adverse events
Device malfunctions
Time frame: 12 months
The number of device malfunction incidents
5 secondary outcomes
Mean gestational age at delivery
Time frame: 12 months
Successful Completion
Time frame: 12 months
Satisfaction scores
Time frame: 12 months
Live births
Time frame: 12 months
Neonatal deaths
Time frame: 12 months
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 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for In Utero Procedure Affecting Fetus or Newborn
Recruiting
The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
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.
Mauro Schenone, M.D. principal investigator
Mayo Clinic
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 New Generation Fetoscope - curved 11508AAK and Karl Storz New Generation Fetoscope - straight 11506AAK in people with In Utero Procedure Affecting Fetus or Newborn, run by Mayo Clinic 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 1 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 12 months). The study lists 3 primary outcomes in all. 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 1 May 2026.