IschemiaNCT02044666
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
A study testing Micronized Small Intestinal Submucosa (SIS) in people with Ischemia and Peripheral Arterial Disease, run by Cook Group Incorporated at 1 site in Canada.
Trial summary
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- What is being tested?
- Micronized Small Intestinal Submucosa (SIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Aug 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
- Patient is unable to be treated by endovascular or surgical means
Who cannot join
- Patient is pregnant or breastfeeding
- Patient has had a previous surgery within 30 days of the study procedure
- Patient has a planned surgical or interventional procedure within 30 days after the study procedure
- Patient has a life expectancy of less than 1 year
- Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
- Additional restrictions as specified in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Being tested
- Micronized Small Intestinal Submucosa (SIS)
- Keywords
- Critical Limb Ischemia, Amputation
- Medical subject headings
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized Small Intestinal Submucosa (SIS)Device
Micronized Small Intestinal Submucosa (SIS)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Micronized Small Intestinal Submucosa (SIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and types of adverse events
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kong Teng Tan, MD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044666
- Sponsor's protocol ID
- 13-004
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2014
- Last updated
- 6 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02044666
- Acronym / sponsor ID
- 13-004
- Keywords
- Critical Limb Ischemia, Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jan 2014 (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.
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
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: Micronized Small Intestinal Submucosa (SIS) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
- Patient is unable to be treated by endovascular or surgical means
Key exclusion criteria (6 listed)
- Patient is pregnant or breastfeeding
- Patient has had a previous surgery within 30 days of the study procedure
- Patient has a planned surgical or interventional procedure within 30 days after the study procedure
- Patient has a life expectancy of less than 1 year
- Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
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 |
|---|---|---|
| Micronized Small Intestinal Submucosa (SIS)Micronized Small Intestinal Submucosa (SIS) | Device | Treatment |
Primary outcome
Frequency and types of adverse events
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Kong Teng Tan, MD principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronized Small Intestinal Submucosa (SIS) in people with Ischemia and Peripheral Arterial Disease, run by Cook Group Incorporated at 1 site in Canada.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jan 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and types of adverse events (time frame: 180 days). 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 6 Jan 2017.