High-type Anal FistulaeNCT00487071
Anal Fistula Plug for High-type Anal Fistulae
A study testing Anal fistula plug in people with High-type Anal Fistulae, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-type Anal Fistulae
- What is being tested?
- Anal fistula plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Aug 2006to Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high-type anal fistulae confirmed by MRI
- Informed consent available
Who cannot join
- Patients with previous fistula surgery
- Patients with Crohn's disease
- Patients allergic to porcine material
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Anal Fistula Plug in the Management of High-type Anal Fistulae: a Pilot Study
The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients.
Read the detailed description
An anal fistula is an abnormal communication between the anal or rectal lumen and the perianal skin. Anal fistulae are described according to the level at which they transgress the anal sphincter. If the internal opening begins above the anal sphincter then the fistula is described as 'high'. Traditional surgery for high-type anal fistulae often requires staged operations with fistulotomy and seton insertion. The surgery usually results in large and deep wounds which can take months to heal. Moreover, risk of faecal incontinence is inevitable because part of the anal sphincter is divided during the surgery.
The Surgisis® anal fistula plug is a minimally invasive and sphincter-preserving alternative to traditional fistula surgery. It is a newly developed biomaterial made from complex collagen obtained from pigs - animals that have a collagen structure almost identical to that of human tissue. During manufacturing of the plug, living cells are removed by special processes to help ensure that no transmittable diseases are present in the tissue. The plug is a conical device and is placed by drawing it through the fistula tract and suturing it in place. As pig collagen is so similar to human collagen, the plug, once implanted, incorporates naturally over time into the human tissue (human cells and tissues will 'grow' into the plug), thus facilitating the closure of the fistula. Preliminary clinical data from USA showed a high fistula closure rate of 87%. The anal fistula plug can also avoid protracted postoperative wound care and minimise the risk of faecal incontinence.
We would like to carry out a pilot study, the aim of which is to evaluate the efficacy and safety of this new anal fistula plug in the management of high-type anal fistulae. This is believed to be the first study of its kind in Hong Kong.
Patients with high-type anal fistulae confirmed by MRI will be recruited into this study. Patients with previous history of fistula surgery, patients with Crohn's disease, and patients with known allergy to porcine material will be excluded. EUA + anal fistula plug will be performed. Outcome measures include fistula healing rate, recurrence rate, and morbidity. Follow-up MRI will be arranged at 3 months and 6 months after the operation to objectively evaluate the healing of the fistulae.
- Conditions
- High-type Anal Fistulae
- Being tested
- Anal fistula plug
- Keywords
- Anal fistula, High-type, Anal fistula plug, Efficacy, Recurrence
- Medical subject headings
- Rectal Fistula, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal fistula plugDevice
| Study group | Role | What they receive |
|---|---|---|
| Anal fistula plug | Experimental | Not described Receives: Device: Anal fistula plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula healing rate and time for fistula closure
Measured: Up to 1 year
Secondary outcomes (2)
Fistula recurrence rate
Measured: Up to 1 year
Morbidity
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startAug 2006
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: No financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-type Anal FistulaeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 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
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, FRCSEd (Gen), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487071
- Sponsor's protocol ID
- CRE-2006.274
- Status last verified
- Feb 2014
- First submitted
- 13 Jun 2007
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Anal Fistula Plug in the Management of High-type Anal Fistulae: a Pilot Study
- ClinicalTrials.gov ID
- NCT00487071
- Acronym / sponsor ID
- CRE-2006.274
- Conditions
- High-type Anal Fistulae
- Keywords
- Anal fistula, High-type, Anal fistula plug, Efficacy, Recurrence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No financial support
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Jun 2007 (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 aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients.
Detailed description
An anal fistula is an abnormal communication between the anal or rectal lumen and the perianal skin. Anal fistulae are described according to the level at which they transgress the anal sphincter. If the internal opening begins above the anal sphincter then the fistula is described as 'high'. Traditional surgery for high-type anal fistulae often requires staged operations with fistulotomy and seton insertion. The surgery usually results in large and deep wounds which can take months to heal. Moreover, risk of faecal incontinence is inevitable because part of the anal sphincter is divided during the surgery.
The Surgisis® anal fistula plug is a minimally invasive and sphincter-preserving alternative to traditional fistula surgery. It is a newly developed biomaterial made from complex collagen obtained from pigs - animals that have a collagen structure almost identical to that of human tissue. During manufacturing of the plug, living cells are removed by special processes to help ensure that no transmittable diseases are present in the tissue. The plug is a conical device and is placed by drawing it through the fistula tract and suturing it in place. As pig collagen is so similar to human collagen, the plug, once implanted, incorporates naturally over time into the human tissue (human cells and tissues will 'grow' into the plug), thus facilitating the closure of the fistula. Preliminary clinical data from USA showed a high fistula closure rate of 87%. The anal fistula plug can also avoid protracted postoperative wound care and minimise the risk of faecal incontinence.
We would like to carry out a pilot study, the aim of which is to evaluate the efficacy and safety of this new anal fistula plug in the management of high-type anal fistulae. This is believed to be the first study of its kind in Hong Kong.
Patients with high-type anal fistulae confirmed by MRI will be recruited into this study. Patients with previous history of fistula surgery, patients with Crohn's disease, and patients with known allergy to porcine material will be excluded. EUA + anal fistula plug will be performed. Outcome measures include fistula healing rate, recurrence rate, and morbidity. Follow-up MRI will be arranged at 3 months and 6 months after the operation to objectively evaluate the healing of the fistulae.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal fistula plug | Experimental | Device: Anal fistula plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with high-type anal fistulae confirmed by MRI
- Informed consent available
Key exclusion criteria (3 listed)
- Patients with previous fistula surgery
- Patients with Crohn's disease
- Patients allergic to porcine material
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 |
|---|---|---|
| Anal fistula plug | Device | Anal fistula plug |
Primary outcome
Fistula healing rate and time for fistula closure
Time frame: Up to 1 year
2 secondary outcomes
Fistula recurrence rate
Time frame: Up to 1 year
Morbidity
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: No financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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.
Simon SM Ng, FRCSEd (Gen) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal fistula plug in people with High-type Anal Fistulae, run by Chinese University of Hong Kong at 1 site in China.
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 3 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: stopped early, as of the sponsor's last update on 13 Feb 2014. 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 China. 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 was stopped early (reason given: No financial support). Results are not available in the source record.
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?
Fistula healing rate and time for fistula closure (time frame: Up to 1 year). 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 13 Feb 2014.