Twin to Twin Transfusion SyndromeTTTSNCT02506049
Laser Photocoagulation in Twin to Twin Transfusion Syndrome
A study testing S-LPC:Selective Laser Photocoagulation in people with Twin to Twin Transfusion Syndrome, run by University of Tennessee at 2 sites in United States.
Trial summary
Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS). Read more about this study
- Who is it for?
- Ages 16 to 27 weeks, women only
- Conditions the study is for
- Twin to Twin Transfusion Syndrome
- What is being tested?
- S-LPC:Selective Laser Photocoagulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to 28 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 27 weeks
- Women only
- No healthy volunteers
- Child
Who may be able to join
- The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation
Who cannot join
- All other pregnancies not meeting inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Regional One Health, Regional Medical Center, Rout Center for Women and Children
Memphis, Tennessee, 38103
University of Tennessee Health Science Center, OB-GYN
Memphis, Tennessee, 38103
About this study
Official title: Fetoscopic Directed Laser Photocoagulation of Communicating Placental Vessels in Twin to Twin Transfusion Syndrome
Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).
Read the detailed description
Patients initially will be identified by ultrasound examination by their primary provider. Consultation and subsequent ultrasound confirmation will be undertaken by our group. Patients meeting the inclusion criteria will undergo extensive verbal counseling regarding the clinical findings, prognosis, and management options. Those electing to proceed will sign written informed consent documents.
More specifically, after initial referral to our center for TTTS management, patients will undergo targeted ultrasound to confirm the diagnosis. If confirmed, patients will undergo extensive counseling regarding various management options. Those patients electing to proceed with selective laser photocoagulation (S-LPC) will undergo the informed consent process. The S-LPC will be performed in the Labor and Delivery (L\&D), Operating Room (OR) at the Regional Medical Center, Regional One Health (RMC,ROH). In the majority of cases, maternal anesthesia will be an epidural. In those cases where the patient is unable to lay supine due to an enlarged uterus (resulting in maternal hypotension or respiratory insufficiency, or maternal anxiety), general anesthesia with intubation will be administered. In rare cases, intravenous sedation with infiltration of a local anesthetic into the skin, deep muscle, and fascia will be used. Following the administration of maternal anesthesia, ultrasound will be performed to assess fetal position, placentation, and select a site for insertion of the operative instruments. A small skin incision will be made following administration of local anesthetic to allow percutaneous access to the recipient gestational sac. An 18 gauge needle will be inserted through the maternal abdomen and uterus into the gestational sac. Once secured in place, the stylet will be removed and a J guide wire will be inserted through the needle. The needle will be removed and a 10-12 Fr (3-3.4 mm) trocar and cannula will be inserted into the sac over the guide wire. The trocar and guide wire will be removed and the fetoscopy instruments will be introduced through the cannula. The procedure is performed under continuous ultrasound guidance. After introduction of the fetoscope and operating sheath, the placenta is inspected by direct visualization for communicating vessels between the recipient and donor twin. A 400-600 micron laser fiber is introduced into the gestational sac via an instrument channel in the operating sheath. The fiber is directed to the communicating vessels, which are then ablated with thermal energy. An average of 7-15 sites will be ablated. At the completion of the procedure the amniotic fluid volume in the recipient sac will be reduced to a normal volume. Follow-up visits to track maternal and fetal progress after the procedure will be scheduled with our group.
- Conditions
- Twin to Twin Transfusion Syndrome
- Being tested
- S-LPC:Selective Laser Photocoagulation
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-LPC:Selective Laser PhotocoagulationDevice
Under anesthesia (epidural, general anesthesia with intubation, or intravenous sedation with infiltration of a local anesthetic), one treatment with the use of fetoscopy instrument sets for Selective Laser Photocoagulation (S-PLC) to seal the connecting blood vessels, help to normalize blood flow between twins.
| Study group | Role | What they receive |
|---|---|---|
| S-LPC:Selective Laser Photocoagulation | Other | S-LPC seals connecting vessels, normalizes flow between twins Receives: Device: S-LPC:Selective Laser Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser ablation of placental anastomoses for treatment of severe TTTS and establishment of normalized blood flow between the fetal twins.
Once a diagnosis of TTTS has been made, the Fetoscopy Instrument Sets are intended to be used for selective laser photocoagulation (S-LPC) to treat the condition in fetuses whose gestational age is between 16 and 26 weeks. The set consists of a fetoscope, which is essentially an optical device used to view a fetus within the uterus, and sheaths that are used to pass other surgical instruments and/or fluid through the entry site, which is a tiny incision in the mother's abdomen. The instruments are inserted using ultrasound guidance and, once the shared blood vessels on the placenta are identified using the fetoscope, a laser can be passed through the sheath. The laser is used to photocoagulate the shared vessels. This helps to normalize the flow of blood between the twins. After all target vessels are identified and treated with S-LPC, the laser, fetoscope, and sheath are removed.
Measured: The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation;procedure will last approx 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2010
- Primary completion15 Aug 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin to Twin Transfusion SyndromeStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Medical Center, Regional One Health
- Responsible party
- Sponsor
- Investigators
- Giancarlo Mari, M.D., MBA, Principal investigator, Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506049
- Sponsor's protocol ID
- 10-00755-HUD
- Acronym
- TTTS
- Status last verified
- Jan 2019
- First submitted
- 6 Jul 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetoscopic Directed Laser Photocoagulation of Communicating Placental Vessels in Twin to Twin Transfusion Syndrome
- ClinicalTrials.gov ID
- NCT02506049
- Acronym / sponsor ID
- TTTS / 10-00755-HUD
- Conditions
- Twin to Twin Transfusion Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Regional Medical Center, Regional One Health
- Study start
- Apr 2010
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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.
Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).
Detailed description
Patients initially will be identified by ultrasound examination by their primary provider. Consultation and subsequent ultrasound confirmation will be undertaken by our group. Patients meeting the inclusion criteria will undergo extensive verbal counseling regarding the clinical findings, prognosis, and management options. Those electing to proceed will sign written informed consent documents.
More specifically, after initial referral to our center for TTTS management, patients will undergo targeted ultrasound to confirm the diagnosis. If confirmed, patients will undergo extensive counseling regarding various management options. Those patients electing to proceed with selective laser photocoagulation (S-LPC) will undergo the informed consent process. The S-LPC will be performed in the Labor and Delivery (L\&D), Operating Room (OR) at the Regional Medical Center, Regional One Health (RMC,ROH). In the majority of cases, maternal anesthesia will be an epidural. In those cases where the patient is unable to lay supine due to an enlarged uterus (resulting in maternal hypotension or respiratory insufficiency, or maternal anxiety), general anesthesia with intubation will be administered. In rare cases, intravenous sedation with infiltration of a local anesthetic into the skin, deep muscle, and fascia will be used. Following the administration of maternal anesthesia, ultrasound will be performed to assess fetal position, placentation, and select a site for insertion of the operative instruments. A small skin incision will be made following administration of local anesthetic to allow percutaneous access to the recipient gestational sac. An 18 gauge needle will be inserted through the maternal abdomen and uterus into the gestational sac. Once secured in place, the stylet will be removed and a J guide wire will be inserted through the needle. The needle will be removed and a 10-12 Fr (3-3.4 mm) trocar and cannula will be inserted into the sac over the guide wire. The trocar and guide wire will be removed and the fetoscopy instruments will be introduced through the cannula. The procedure is performed under continuous ultrasound guidance. After introduction of the fetoscope and operating sheath, the placenta is inspected by direct visualization for communicating vessels between the recipient and donor twin. A 400-600 micron laser fiber is introduced into the gestational sac via an instrument channel in the operating sheath. The fiber is directed to the communicating vessels, which are then ablated with thermal energy. An average of 7-15 sites will be ablated. At the completion of the procedure the amniotic fluid volume in the recipient sac will be reduced to a normal volume. Follow-up visits to track maternal and fetal progress after the procedure will be scheduled with our group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-LPC:Selective Laser Photocoagulation | Other | Device: S-LPC:Selective Laser PhotocoagulationS-LPC seals connecting vessels, normalizes flow between twins |
Who may qualify
- Ages
- 16 to 27 weeks
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation
Key exclusion criteria (1 listed)
- All other pregnancies not meeting inclusion criteria
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 |
|---|---|---|
| S-LPC:Selective Laser PhotocoagulationUnder anesthesia (epidural, general anesthesia with intubation, or intravenous sedation with infiltration of a local anesthetic), one treatment with the use of fetoscopy instrument sets for Selective Laser Photocoagulation (S-PLC) to seal the connecting blood vessels, help to normalize blood flow between twins. | Device | S-LPC:Selective Laser Photocoagulation |
Primary outcome
Laser ablation of placental anastomoses for treatment of severe TTTS and establishment of normalized blood flow between the fetal twins.
Time frame: The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation;procedure will last approx 1 hour
Once a diagnosis of TTTS has been made, the Fetoscopy Instrument Sets are intended to be used for selective laser photocoagulation (S-LPC) to treat the condition in fetuses whose gestational age is between 16 and 26 weeks. The set consists of a fetoscope, which is essentially an optical device used to view a fetus within the uterus, and sheaths that are used to pass other surgical instruments and/or fluid through the entry site, which is a tiny incision in the mother's abdomen. The instruments are inserted using ultrasound guidance and, once the shared blood vessels on the placenta are identified using the fetoscope, a laser can be passed through the sheath. The laser is used to photocoagulate the shared vessels. This helps to normalize the flow of blood between the twins. After all target vessels are identified and treated with S-LPC, the laser, fetoscope, and sheath are removed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Twin to Twin Transfusion Syndrome
Active, not recruitingObservational study
Database of Monochorionic Pregnancies
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
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The Effect of Uterine Entry In Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
Twin to Twin Transfusion
Not yet recruiting
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Twin to Twin Transfusion Syndrome
Recruiting
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
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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. This study is not recruiting at the moment.
Giancarlo Mari, M.D., MBA principal investigator
Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-LPC:Selective Laser Photocoagulation in people with Twin to Twin Transfusion Syndrome, run by University of Tennessee at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Laser ablation of placental anastomoses for treatment of severe TTTS and establishment of normalized blood flow between the fetal twins. (time frame: The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation;procedure will last approx 1 hour). 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 13 Nov 2020.