Pelvic Organ ProlapseNCT03748693
Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Hillel Yaffe Medical Center.
Trial summary
The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Hysterectomy and Colporrhaphy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Sep 2019
- Phase
- Observational
- 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 80 years
- Women only
- Adult, Older adult
Study population: Women attending our OB/GYN department because of POP and other gynecological disorders
Who may be able to join
- Women with POP undergoing colporrhaphy
- Women undergoing hysterectomy
Who cannot join
- Autoimmune and connective tissue disorders
- Cancer in genital tract
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.
We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Hysterectomy, Colporrhaphy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Surgery performed on women with a variety of gynecological indications
ColporrhaphyProcedure or surgery
Surgery performed on women with POP
| Study group | Role | What they receive |
|---|---|---|
| POP Group | Women with POP undergoing surgery in our OB/GYN department. Receives: Procedure: Colporrhaphy | |
| Non-POP Group | Women undergoing hysterectomy for other indications. Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response in POP
Tissue biopsy will analyzed for IMC and compared to control group
Measured: Two weeks
Cytokine environment in POP
Tissue biopsy will analyzed for cytokine environment and compared to control group
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748693
- Sponsor's protocol ID
- HYMC-0073-18
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03748693
- Acronym / sponsor ID
- HYMC-0073-18
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Nov 2018 (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 aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.
We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POP Group | – | Procedure: ColporrhaphyWomen with POP undergoing surgery in our OB/GYN department. |
| Non-POP Group | – | Procedure: HysterectomyWomen undergoing hysterectomy for other indications. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women attending our OB/GYN department because of POP and other gynecological disorders
Key inclusion criteria (2 listed)
- Women with POP undergoing colporrhaphy
- Women undergoing hysterectomy
Key exclusion criteria (2 listed)
- Autoimmune and connective tissue disorders
- Cancer in genital tract
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 |
|---|---|---|
| HysterectomySurgery performed on women with a variety of gynecological indications | Procedure or surgery | Non-POP Group |
| ColporrhaphySurgery performed on women with POP | Procedure or surgery | POP Group |
Primary outcome
Immune response in POP
Time frame: Two weeks
Tissue biopsy will analyzed for IMC and compared to control group
Cytokine environment in POP
Time frame: Two weeks
Tissue biopsy will analyzed for cytokine environment and compared to control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Hillel Yaffe Medical Center.
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 2 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mariana Ordonez, MD (972-52-3243474, malo_mariana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response in POP (time frame: Two weeks). The study lists 2 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 21 Nov 2018.