Fecal IncontinencePURSUITNCT03940573
Pursuit: Real World Use of the Eclipse System
A study testing Eclipse Insert in people with Fecal Incontinence, run by Pelvalon, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Eclipse Insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Apr 2019to 31 Dec 2021
- Phase
- Interventional
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female
- Diagnosis of Fecal Incontinence
- Clinician recommendation of the Eclipse System
- Subject provides informed consent and HIPAA authorization
- No Exclusion Criteria.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
The American Association of Female Pelvic Medicine
Agoura Hills, California, 91301
Shirley Louis, 818-991-0988
Sherry Thomas, MD
- Recruiting
The Ob-Gyn and Incontinence Center
Arcadia, California, 91006
Kumar Kothandaraman
Prema Kothandaraman, MD
- Recruiting
Florida Urogynecology, LLC
Jacksonville, Florida, 32216
Darlene Jones, 904-652-0373
Jason Thompson, MD
- Not yet recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Paul Pettit, MD, 904-953-2977, paul.pettit@mayo.edu
- Recruiting
Long Beach Urogynecology
Long Beach, California, 90806
Dara France, 562-426-4904
Jocelyn Craig, MD
- Recruiting
Princeton Urogynecology
Princeton, New Jersey, 08540
Alison Shaltis, 609-924-2230
Heather van Raalte, MD
About this study
Official title: A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
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.
Read the detailed description
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.
- Conditions
- Fecal Incontinence
- Being tested
- Eclipse Insert
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eclipse InsertDevice
Rectal Control System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients fitted with the device. Receives: Device: Eclipse Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit Rate
Proportion of patients successfully fit
Measured: 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
Measured: 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)
Measured: 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)
Measured: 12 months
Secondary outcomes (6)
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Measured: 3 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Measured: 6 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start19 Apr 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pelvalon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Pettit, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940573
- Sponsor's protocol ID
- CA007
- Acronym
- PURSUIT
- Status last verified
- Mar 2021
- First submitted
- 2 May 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
- ClinicalTrials.gov ID
- NCT03940573
- Acronym / sponsor ID
- PURSUIT / CA007
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pelvalon, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 May 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Eclipse InsertAll patients fitted with the device. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult female
- Diagnosis of Fecal Incontinence
- Clinician recommendation of the Eclipse System
- Subject provides informed consent and HIPAA authorization
- No Exclusion Criteria.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eclipse InsertRectal Control System. | Device | Treatment |
Primary outcome
Fit Rate
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Proportion of patients successfully fit
Device Size Distribution
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Size distribution of devices among successfully fit patients
St. Mark's Score (Vaizey)
Time frame: 12 months
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
PGI-I Score
Time frame: 12 months
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
6 secondary outcomes
St. Mark's Score (Vaizey)
Time frame: 3 months
St. Mark's Score (Vaizey)
Time frame: 6 months
St. Mark's Score (Vaizey)
Time frame: 9 months
PGI-I Score
Time frame: 3 months
PGI-I Score
Time frame: 6 months
PGI-I Score
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Pelvalon, Eclipse manufacturer and Study Sponsor, websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Fecal Incontinence
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
Active, not recruitingPhase 2/3
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Fecal Incontinence
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.
Paul Pettit, MD principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eclipse Insert in people with Fecal Incontinence, run by Pelvalon, Inc. at 6 sites 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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Herbowy (6507966294, Steve@pelvalon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fit Rate (time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening). The study lists 4 primary outcomes in all. 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 11 Mar 2021.