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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intrauterine Adhesions (IUA) | 3, 6 or 12 months post-ablation |
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Inclusion Criteria:
Exclusion Criteria:
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Women who meet eligibility criteria having undergone a prior endometrial ablation 3, 6 or 12 months prior to the second look hysteroscopy
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Basinski, MD | Basinski and Juran MDs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basinksi and Juran, MD's | Newburgh | Indiana | 47630 | United States |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |