Condition or disease | Intervention/treatment |
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Pelvic Pain Syndrome | Device: Duplex US |
Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization
Study Type : | Observational |
Estimated Enrollment : | 25 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Duplex US in Pelvic Congestion Syndrome in Females |
Estimated Study Start Date : | May 10, 2019 |
Estimated Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | October 2019 |
Tracking Information | |||||||
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First Submitted Date | May 7, 2019 | ||||||
First Posted Date | May 9, 2019 | ||||||
Last Update Posted Date | May 9, 2019 | ||||||
Estimated Study Start Date | May 10, 2019 | ||||||
Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Duplex US in Pelvic Congestion Syndrome in females [ Time Frame: 6 months ] to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Duplex US in Pelvic Congestion Syndrome in Females (PCS) | ||||||
Official Title | Duplex US in Pelvic Congestion Syndrome in Females | ||||||
Brief Summary | To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome | ||||||
Detailed Description |
Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome | ||||||
Condition | Pelvic Pain Syndrome | ||||||
Intervention | Device: Duplex US
Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome
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Study Groups/Cohorts | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
25 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | October 2019 | ||||||
Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 25 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03943381 | ||||||
Other Study ID Numbers | Duplex US in PCS | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Mohamed AbuDeif Sayed, Assiut University | ||||||
Study Sponsor | Assiut University | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Assiut University | ||||||
Verification Date | April 2019 |