An interventional study of Eclipse Insert in Fecal Incontinence, sponsored by Pelvalon, Inc.. Status unknown at 6 sites in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Pelvalon, Inc. · Not applicable, Interventional, and Treatment
A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period.
Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.
During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Pelvalon, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
No Exclusion Criteria.
All patients fitted with the device.
Device: Eclipse Insert
Rectal Control System.
Fit Rate
Proportion of patients successfully fit
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Device Size Distribution
Size distribution of devices among successfully fit patients
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 12 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time frame: 12 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 3 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 6 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 9 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time frame: 3 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)e
Time frame: 6 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time frame: 9 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Pelvalon, Inc.