Intrauterine AdhesionNCT04824430
Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
An observational study of Intrauterine Adhesion, run by Rejoni Inc. at 1 site in United States.
Trial summary
The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to 22 Jul 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who meet eligibility criteria having undergone a prior endometrial ablation 3, 6 or 12 months prior to the second look hysteroscopy
Who may be able to join
- Premenopausal female patients ≥ 18 years of age
- Patient has undergone endometrial ablation within the prior 14 months.
- There were no contraindications for endometrial ablation as specified in Ablation System labeling
- Patient agrees to undergo an SLH either at 3, 6 or 12 months post-ablation
- Patient abstained from any form of hormonal contraception including an IUD after the ablation and through the period that the SLH is performed.
- Patient has signed the IRB approved informed consent.
Who cannot join
- Additional intrauterine procedures performed between time of endometrial ablation and the SLH; e.g., endometrial and/or myometrial resection.
- IUD in situ
- Pregnant (positive urine pregnancy test) or lactating
- Active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis).
- Systemic steroid within 1 week of endometrial ablation
- Previous adhesiolysis procedure or diagnosis of Asherman's disease.
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- No noted clinically significant uterine anomalies at the time of the ablation (e.g., septate uterus or other anomalies that distorts the uterine cavity)
- Any other condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
- Participating or considering participation in a clinical trial of another investigational drug or device during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions (IUA) 3, 6 and 12 Months Following Endometrial Ablation: A Prospective Single-Center Observational Study
The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.
Read the detailed description
Prospective single center observational study. Up to 30 subjects will be enrolled (up to 10 subjects per time point). Patients who sign the Institutional Review Board (IRB) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. Patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (SLH) as assigned by the Investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). A diagnostic SLH will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. The ability to access the uterine cavity (or not) will be documented.
- Conditions
- Intrauterine Adhesion
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLH 3M | Second look hysteroscopy (SLH) performed 3 months post-ablation | |
| SLH 6M | Second look hysteroscopy (SLH) performed 6 months post-ablation | |
| SLH 12M | Second look hysteroscopy (SLH) performed 12 months post-ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intrauterine Adhesions (IUA)
Measured: 3, 6 or 12 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start23 Mar 2021
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rejoni Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cindy Basinski, MD, Principal investigator, Basinski and Juran MDs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824430
- Sponsor's protocol ID
- EA 21-001
- Status last verified
- Jun 2022
- First submitted
- 24 Mar 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions (IUA) 3, 6 and 12 Months Following Endometrial Ablation: A Prospective Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT04824430
- Acronym / sponsor ID
- EA 21-001
- Conditions
- Intrauterine Adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rejoni Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 1 Apr 2021 (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 objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.
Detailed description
Prospective single center observational study. Up to 30 subjects will be enrolled (up to 10 subjects per time point). Patients who sign the Institutional Review Board (IRB) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. Patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (SLH) as assigned by the Investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). A diagnostic SLH will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. The ability to access the uterine cavity (or not) will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLH 3M | – | –Second look hysteroscopy (SLH) performed 3 months post-ablation |
| SLH 6M | – | –Second look hysteroscopy (SLH) performed 6 months post-ablation |
| SLH 12M | – | –Second look hysteroscopy (SLH) performed 12 months post-ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who meet eligibility criteria having undergone a prior endometrial ablation 3, 6 or 12 months prior to the second look hysteroscopy
Key inclusion criteria (6 listed)
- Premenopausal female patients ≥ 18 years of age
- Patient has undergone endometrial ablation within the prior 14 months.
- There were no contraindications for endometrial ablation as specified in Ablation System labeling
- Patient agrees to undergo an SLH either at 3, 6 or 12 months post-ablation
- Patient abstained from any form of hormonal contraception including an IUD after the ablation and through the period that the SLH is performed.
Key exclusion criteria (9 listed)
- Additional intrauterine procedures performed between time of endometrial ablation and the SLH; e.g., endometrial and/or myometrial resection.
- IUD in situ
- Pregnant (positive urine pregnancy test) or lactating
- Active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis).
- Systemic steroid within 1 week of endometrial ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Intrauterine Adhesions (IUA)
Time frame: 3, 6 or 12 months post-ablation
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 16 Jun 2022.
- 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.
Cindy Basinski, MD principal investigator
Basinski and Juran MDs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Adhesion, run by Rejoni Inc. 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 6 inclusion and 9 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 16 Jun 2022. 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?
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?
Incidence of Intrauterine Adhesions (IUA) (time frame: 3, 6 or 12 months post-ablation). 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 16 Jun 2022.