Crohn DiseaseUPpCroNCT03776825
Permacol Paste in Perianal Crohn's Disease
An observational study of Crohn Disease and Perianal Fistula, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Perianal Fistula
- What is being tested?
- Permacol Paste
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2019to 1 Oct 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Perianal Crohn's Disease Patients
Who may be able to join
- Age > 18, any sex
- Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
- Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
- Non-active or mildly active luminal CD defined by a CDAI < 220
Who cannot join
- CDAI > 220
- Dominant luminal active CD requiring immediate surgical or medical therapy
- Fistula with > 3 external openings and > 2 internal openings
- Severe active proctitis and/or rectal stenosis
- Abscess or pelvic collection > 2 cm diameter
- Concomitant rectovaginal fistulas
- Concomitant steroid treatment or treated with steroids in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, MI, 20089
Francesca Di Candido, MD, 0282247776, francesca.di_candido@humanitas.it
Annalisa Maroli, PhD, +390282247776, annalisa.maroli@humanitas.it
About this study
Official title: Use of Permacol Paste in Perianal Crohn's Disease
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.
Read the detailed description
This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.
- Conditions
- Crohn Disease, Perianal Fistula
- Being tested
- Permacol Paste
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permacol PasteDevice
Permacol Paste Injection
| Study group | Role | What they receive |
|---|---|---|
| Perianal Crohn's Disease | Permacol Paste injection Receives: Device: Permacol Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal fistula closure rate
Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure
Measured: 12 months
Secondary outcomes (2)
Patients quality of life
Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life (IBDQ). IBDQ is a disease-specific questionnaire included 32 questions. The questions consisted of 4 domains as follows: Bowel symptoms (10 questions), systemic symptoms (5 questions), emotional functioning (12 questions), and social functioning (5 questions). Every question score ranged from 1 to 7 which 7 corresponded to the highest level of functioning. Total score ranged from 32 to 224. Higher score showed higher quality of life.
Measured: 12 months
Patients continence
Continence will be assessed by means of the Cleveland Clinic Incontinence Score (CCIS, or Wexner scale). This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start7 Feb 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776825
- Sponsor's protocol ID
- 2134
- Acronym
- UPpCro
- Status last verified
- Feb 2021
- First submitted
- 8 Jun 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
La Raja C, Maroli A, Foppa C, Gabbiadini R, Dal Buono A, Armuzzi A, Carvello M, Spinelli A. Collagen Paste Injection in Crohn's Disease Perianal Fistula: Long-term Outcomes of a Pilot, Prospective Cohort Study. J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024.
PubMed 39473704
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Permacol Paste in Perianal Crohn's Disease
- ClinicalTrials.gov ID
- NCT03776825
- Acronym / sponsor ID
- UPpCro / 2134
- Conditions
- Crohn Disease, Perianal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 17 Dec 2018 (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.
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.
Detailed description
This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perianal Crohn's Disease | – | Device: Permacol PastePermacol Paste injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Perianal Crohn's Disease Patients
Key inclusion criteria (4 listed)
- Age > 18, any sex
- Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
- Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
- Non-active or mildly active luminal CD defined by a CDAI < 220
Key exclusion criteria (7 listed)
- CDAI > 220
- Dominant luminal active CD requiring immediate surgical or medical therapy
- Fistula with > 3 external openings and > 2 internal openings
- Severe active proctitis and/or rectal stenosis
- Abscess or pelvic collection > 2 cm diameter
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 |
|---|---|---|
| Permacol PastePermacol Paste Injection | Device | Perianal Crohn's Disease |
Primary outcome
Perianal fistula closure rate
Time frame: 12 months
Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure
2 secondary outcomes
Patients quality of life
Time frame: 12 months
Patients continence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 39473704La Raja C, Maroli A, Foppa C, Gabbiadini R, Dal Buono A, Armuzzi A, Carvello M, Spinelli A. Collagen Paste Injection in Crohn's Disease Perianal Fistula: Long-term Outcomes of a Pilot, Prospective Cohort Study. J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Antonino Spinelli, MD, PhD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Perianal Fistula, run by Istituto Clinico Humanitas at 1 site in Italy.
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 4 inclusion and 7 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 3 Feb 2021. 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 Italy. 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 Francesca Di Candido, MD (+390282247776, francesca.di_candido@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perianal fistula closure rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776825, which also lists 1 linked publication.
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 3 Feb 2021.