Anal FistulasPhase 2NCT02456324
A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
A Phase 2 study testing PICS-AF Device in people with Anal Fistulas and Rectal Fistulas, run by Curaseal Inc. at 1 site in Spain.
Trial summary
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal fistulas. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Fistulas, Rectal Fistulas
- What is being tested?
- PICS-AF Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Aug 2016
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- Subject must be at least 18 years of age and no older than 75 years of age.
- Subject has been diagnosed with a single internal opening anorectal fistula (not multiple internal openings) that is clinically indicated for treatment.
- Subject must have a fistula tract that is > 2.0 cm in length based on measurements from imaging studies or upon probing of the fistula tract.
- Subject should have a clean and infection-free fistula tract that has been properly drained.
- Subject must be able to comply with study and study follow-up requirements.
Who cannot join
- Subject with a life expectancy < 6 months.
- Subject with anorectal fistula due to Crohn's disease or malignancy.
- Subject is severely malnourished.
- Subject with a history of sensitivity or allergy to bovine materials.
- Subject is on active chemotherapy treatment that may interfere with wound healing.
- Subject has an active infection (cellulitis) or an undrained abscess in fistula tract.
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- Subject has a horseshoe fistula tract.
- Subject has a history of radiation therapy to anus or rectum.
- Subject is affected by uncontrolled diabetes.
- Subjects with subcutaneous, ano-vaginal, or pouch-vaginal fistula.
- Subject presents with end stage renal disease requiring dialysis.
- Subject is pregnant or planning to become pregnant (verbal report).
- Subject is unable or unwilling to provide informed consent.
- Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Subject has an American Society of Anesthesia PS classification of greater than 3.
- Subject is known to be a carrier for drug-resistant bacteria.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hosptial Universitario VIRGEN DEL ROCIO
Seville, Sevilla, 41013
Fernando de la Portilla, MD
Fernando de la Portilla, MD
About this study
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal fistulas.
Read the detailed description
The primary objective of this post-market study is to generate clinical data to evaluate the performance and safety of the PICS AF devices for the treatment of anorectal fistulas and to compare success rates of fistula closure to historical controls of commercially available devices for anorectal fistula repair performed at the participating clinical sites. Data will be obtained from this study to support the safety and effectiveness of the PICS AF device for promoting fistula closure and healing.
PRIMARY EFFECTIVENESS ENDPOINT:
Fistula closure success at 6 months is defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Fistula closure success for the PICS-AF device will be assessed at the 6 month follow up visit using MRI. The rate of the PICS-AF closure success at 6 months will compared to the closure rate obtained from historical controls that were followed for similar time periods.
PRIMARY SAFETY ENDPOINT:
The proportion of subjects experiencing a serious adverse event (i.e., an infection, enlargement of the fistula, an allergic reaction to the PICS-AF device, etc.) through 6 months of post-procedure follow-up.
SECONDARY ENDPOINTS:
- Fistula closure at 3 months post-procedure as determined by physical examination.
- The cessation of egress of enteric fluid from the fistula tract or stable complete closure of the mucosal internal fistula opening by physical examination.
- Safety post-procedure through 3-month follow-up period.
- Infection (e.g., systemic or abscess).
- Time to fistula closure.
- Need for repeat procedure or other required surgical intervention.
- Incontinence levels before and after treatment.
- Quality of life assessments before and after treatment.
- Conditions
- Anal Fistulas, Rectal Fistulas
- Being tested
- PICS-AF Device, Historical Controls Treated with Commercially Available Fistula Plugs
- Keywords
- Fistula, Anorectal
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICS-AF DeviceDevice
This is a specialized closure system for anorectal fistulas that is sphincter sparing
Historical Controls Treated with Commercially Available Fistula PlugsDevice
These are patients previously treated with commercially available fistula plugs.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients Treated with PICS-AF device Receives: Device: PICS-AF Device |
| Historical Controls | Other | Patients Treated with Commercially Available Fistula Plug Devices at Same Sites Receives: Device: Historical Controls Treated with Commercially Available Fistula Plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Closure
Defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Confirmed by MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curaseal Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456324
- Sponsor's protocol ID
- TP0777
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
- ClinicalTrials.gov ID
- NCT02456324
- Acronym / sponsor ID
- TP0777
- Conditions
- Anal Fistulas, Rectal Fistulas
- Keywords
- Fistula, Anorectal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Curaseal Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- 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.
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal fistulas.
Detailed description
The primary objective of this post-market study is to generate clinical data to evaluate the performance and safety of the PICS AF devices for the treatment of anorectal fistulas and to compare success rates of fistula closure to historical controls of commercially available devices for anorectal fistula repair performed at the participating clinical sites. Data will be obtained from this study to support the safety and effectiveness of the PICS AF device for promoting fistula closure and healing.
PRIMARY EFFECTIVENESS ENDPOINT:
Fistula closure success at 6 months is defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Fistula closure success for the PICS-AF device will be assessed at the 6 month follow up visit using MRI. The rate of the PICS-AF closure success at 6 months will compared to the closure rate obtained from historical controls that were followed for similar time periods.
PRIMARY SAFETY ENDPOINT:
The proportion of subjects experiencing a serious adverse event (i.e., an infection, enlargement of the fistula, an allergic reaction to the PICS-AF device, etc.) through 6 months of post-procedure follow-up.
SECONDARY ENDPOINTS:
- Fistula closure at 3 months post-procedure as determined by physical examination.
- The cessation of egress of enteric fluid from the fistula tract or stable complete closure of the mucosal internal fistula opening by physical examination.
- Safety post-procedure through 3-month follow-up period.
- Infection (e.g., systemic or abscess).
- Time to fistula closure.
- Need for repeat procedure or other required surgical intervention.
- Incontinence levels before and after treatment.
- Quality of life assessments before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: PICS-AF DevicePatients Treated with PICS-AF device |
| Historical Controls | Other | Device: Historical Controls Treated with Commercially Available Fistula PlugsPatients Treated with Commercially Available Fistula Plug Devices at Same Sites |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- Subject must be at least 18 years of age and no older than 75 years of age.
- Subject has been diagnosed with a single internal opening anorectal fistula (not multiple internal openings) that is clinically indicated for treatment.
- Subject must have a fistula tract that is > 2.0 cm in length based on measurements from imaging studies or upon probing of the fistula tract.
- Subject should have a clean and infection-free fistula tract that has been properly drained.
Key exclusion criteria (16 listed)
- Subject with a life expectancy < 6 months.
- Subject with anorectal fistula due to Crohn's disease or malignancy.
- Subject is severely malnourished.
- Subject with a history of sensitivity or allergy to bovine materials.
- Subject is on active chemotherapy treatment that may interfere with wound healing.
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 |
|---|---|---|
| PICS-AF DeviceThis is a specialized closure system for anorectal fistulas that is sphincter sparing | Device | Treatment Group |
| Historical Controls Treated with Commercially Available Fistula PlugsThese are patients previously treated with commercially available fistula plugs. | Device | Historical Controls |
Primary outcome
Fistula Closure
Time frame: 6 months
Defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Confirmed by MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PICS-AF Device in people with Anal Fistulas and Rectal Fistulas, run by Curaseal Inc. at 1 site in Spain.
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 6 inclusion and 16 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kenton D Fong, MD (650-799-6298, kfong@curaseal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula Closure (time frame: 6 months). 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 28 May 2015.