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NCT01300884 · ClinicalTrials.gov registry record
Sierra High Definition Ano-Rectal Manometry
A clinical trial of Constipation and Fecal Incontinence, sponsored by Augusta University.
- Completed
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT01300884: Completed study of Constipation and Fecal Incontinence, sponsored by Augusta University.
NCT01300884 is a study of Constipation and Fecal Incontinence that has completed, run by Augusta University. The registered enrollment target is 80 participants, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300884, a study of Constipation and Fecal Incontinence, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence or constipation. Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry. Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.
Conditions Studied
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-12 |
What the finished NCT01300884 record still lists
NCT01300884 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Constipation appearing as the primary indexed condition, and to 0 interventions.
NCT01300884 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT01300884 about?
NCT01300884 is a clinical study titled "Sierra High Definition Ano-Rectal Manometry". Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and ...
What is the current status of trial NCT01300884?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2008-02. Estimated completion is 2011-12.
What conditions does trial NCT01300884 study?
This clinical trial studies the following conditions: Constipation, Fecal Incontinence.
Who is sponsoring clinical trial NCT01300884?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01300884 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01300884's enrollment target sits among peer trials
80 24th of 54 higher than 31 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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