Uterine AnomalytransplantNCT04249791
Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient.
A study testing Transplantation of the uterus from live donor. in people with Uterine Anomaly, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Anomaly
- What is being tested?
- Transplantation of the uterus from live donor.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jun 2019to 25 Jun 2021
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
- At least one pregnancy before
Who cannot join
- comorbidities that contraindicate a surgical procedure
- Women who do not understand the study;
- Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
- ABO blood test mismatch between donor and recipient patient.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784400
Marcelo A Vieira, MD, +551733216600 ext. 7130, mvieiraonco@gmail.com
About this study
Official title: Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.
Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.
Read the detailed description
Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.
- Conditions
- Uterine Anomaly
- Being tested
- Transplantation of the uterus from live donor.
- Keywords
- uterine transplant, robotic surgery, donor, recipient, uterine anomaly
- Medical subject headings
- Uterine Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of the uterus from live donor.Procedure or surgery
Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.
| Study group | Role | What they receive |
|---|---|---|
| Uterus Transplantation | Experimental | Patients undergo transplantation of the uterus from live donor. Receives: Procedure: Transplantation of the uterus from live donor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
transplant sucess rate
Assessed by records from Barretos Cancer Hospital
Measured: 2 years after transplantation
Secondary outcomes (2)
Live births after uterus transplantion
Assessed by records from Barretos Cancer Hospital
Measured: 2 years after transplantation
Pregnancy rate
Assessed by records from Barretos Cancer Hospital
Measured: 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start25 Jun 2019
- Primary completion25 Jun 2020 (estimated)
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine AnomalyStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- MARCELO DE A VIEIRA, MD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249791
- Sponsor's protocol ID
- Uterine Transplant
- Acronym
- transplant
- Status last verified
- Aug 2019
- First submitted
- 7 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vieira MA, Souza C, Nobrega L, Reis R, Andrade C, Schmidt R, Carvalho L. Uterine Transplantation with Robot-assisted Uterus Retrieval from Living Donor: First Case in Brazil. J Minim Invasive Gynecol. 2021 Nov;28(11):1817. doi: 10.1016/j.jmig.2021.08.028. Epub 2021 Sep 4.
PubMed 34487890
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.
- ClinicalTrials.gov ID
- NCT04249791
- Acronym / sponsor ID
- transplant / Uterine Transplant
- Conditions
- Uterine Anomaly
- Keywords
- uterine transplant, robotic surgery, donor, recipient, uterine anomaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 25 Jun 2020 (estimated)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 31 Jan 2020 (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.
Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.
Detailed description
Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterus Transplantation | Experimental | Procedure: Transplantation of the uterus from live donor.Patients undergo transplantation of the uterus from live donor. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
- At least one pregnancy before
Key exclusion criteria (4 listed)
- comorbidities that contraindicate a surgical procedure
- Women who do not understand the study;
- Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
- ABO blood test mismatch between donor and recipient patient.
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 |
|---|---|---|
| Transplantation of the uterus from live donor.Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient. | Procedure or surgery | Uterus Transplantation |
Primary outcome
transplant sucess rate
Time frame: 2 years after transplantation
Assessed by records from Barretos Cancer Hospital
2 secondary outcomes
Live births after uterus transplantion
Time frame: 2 years after transplantation
Pregnancy rate
Time frame: 2 years after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 34487890Vieira MA, Souza C, Nobrega L, Reis R, Andrade C, Schmidt R, Carvalho L. Uterine Transplantation with Robot-assisted Uterus Retrieval from Living Donor: First Case in Brazil. J Minim Invasive Gynecol. 2021 Nov;28(11):1817. doi: 10.1016/j.jmig.2021.08.028. Epub 2021 Sep 4.
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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.
MARCELO DE A VIEIRA, MD principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplantation of the uterus from live donor. in people with Uterine Anomaly, run by Barretos Cancer Hospital at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCELO DE A VIEIRA, MD (+ 55 1733216600 ext. 7130, mvieiraonco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transplant sucess rate (time frame: 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249791, which also lists 1 linked publication.
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 31 Jan 2020.