Rectovaginal FistulaLIPOPLUGNCT06813768
Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
A study testing Microfractured adipose tissue injection and plug placement in people with Rectovaginal Fistula and Crohn Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectovaginal Fistula, Crohn Disease
- What is being tested?
- Microfractured adipose tissue injection and plug placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2023to 30 Mar 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Crohn's disease
- presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
- The patient has received, understood and signed the informed consent to actively participate in the study.
- The patient is able to understand the conditions of the study and to participate for the whole duration.
Who cannot join
- presence of oostomy
- Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
- Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
- Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
- Patients with active oncological or lymphoproliferative diseases
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
About this study
Official title: Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial
Read the detailed description
The goal of this clinical trial is to compare, the efficacy of
- circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
- endoanal mucosal flap in terms of clinical and radiological healing (combined remission) in patients with Crohn's rectovaginal fistulas refractory to standard treatment,
Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.
- Conditions
- Rectovaginal Fistula, Crohn Disease
- Being tested
- Microfractured adipose tissue injection and plug placement
- Keywords
- MICROFTACTURED ADIPOSE TISSUE, BIOLOGIC MESH, ENDOANAL FLAP, LIPOSUCTION
- Medical subject headings
- Rectovaginal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfractured adipose tissue injection and plug placementDevice
Also called Lipogems LGD 60 CND V0599 - RDM 1256088, Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R
surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Microfractured adipose tissue injection and plug placement | Experimental | Liposuction (up to 100 cc of adipose tissue) Processing of adipose tissue with lipogems system Drainage of sepsis, courettage of fistula tract Placement of biological prosthesis in the fistula tract, suturing the mesh with interrupted PDS sutures at the internal sphincter Injection of 15 cc of microfractured adipose tissue into the submucosa around the internal orifice and along the fistula tract Receives: Device: Microfractured adipose tissue injection and plug placement |
| endoanal mucosa flap | Active comparator | A 6-0 absorbable suture will be placed on the skin at the level of the thigh to simulate liposuction Drainage of sepsis, courettage of fistula tract A U-shaped or vertical endoanal mucous flap will be made, after infiltration with 1:100,000 adrenaline of the mucosa surrounding the internal orifice, mobilization of the mucous flap, closure of the internal orifice at the muscular level with 2-0 absorbable stitches of PDS and suture of the mucosal flap with 3-0 absorbable vycril sutures. Receives: Device: Microfractured adipose tissue injection and plug placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined remission
clinical (absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) and radiological (absence of abscesses > 3 mm) closure of the fistula
Measured: 24 weeks
Secondary outcomes (5)
clinical remission
absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) with radiological presence of abscesses > 3 mm
Measured: 12, 16, 20, 24 weeks
clinical response
at least 50% reduction in drainage of the treated vaginal orifice that was draining at baseline despite gentle digital compression.
Measured: 12, 16, 20, 24 weeks
failure
"no change/worsening" of vaginal drainage and patients who, in the judgment of the investigator, require treatment with antibiotics to control recurrent perianal sepsis
Measured: 12, 16, 20, 24 weeks
IBDQ score (quality of life)
changes of Inflammatory Bowel Disease Questionnaire (IBDQ) scores
Measured: 4, 8, 12, 16, 20, 24 weeks
Incidence of adverse events
comparison of incidence of adverse events and serious adverse events in the two arms
Measured: 4, 8, 12, 16, 20, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start7 Jan 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2025 (estimated)
Why it stopped: Study currently suspended due to device-related issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectovaginal FistulaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvio Laureti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813768
- Sponsor's protocol ID
- LIPOPLUG - CROHN
- Acronym
- LIPOPLUG
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)
- ClinicalTrials.gov ID
- NCT06813768
- Acronym / sponsor ID
- LIPOPLUG / LIPOPLUG - CROHN
- Conditions
- Rectovaginal Fistula, Crohn Disease
- Keywords
- MICROFTACTURED ADIPOSE TISSUE, BIOLOGIC MESH, ENDOANAL FLAP, LIPOSUCTION
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study currently suspended due to device-related issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial
Detailed description
The goal of this clinical trial is to compare, the efficacy of
- circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
- endoanal mucosal flap in terms of clinical and radiological healing (combined remission) in patients with Crohn's rectovaginal fistulas refractory to standard treatment,
Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfractured adipose tissue injection and plug placement | Experimental | Device: Microfractured adipose tissue injection and plug placementLiposuction (up to 100 cc of adipose tissue) Processing of adipose tissue with lipogems system Drainage of sepsis, courettage of fistula tract Placement of biological prosthesis in the fistula tract, suturing the mesh with interrupted PDS sutures at the internal sphincter Injection of 15 cc of microfractured adipose tissue into the submucosa around the internal orifice and along the fistula tract |
| endoanal mucosa flap | Active comparator | Device: Microfractured adipose tissue injection and plug placementA 6-0 absorbable suture will be placed on the skin at the level of the thigh to simulate liposuction Drainage of sepsis, courettage of fistula tract A U-shaped or vertical endoanal mucous flap will be made, after infiltration with 1:100,000 adrenaline of the mucosa surrounding the internal orifice, mobilization of the mucous flap, closure of the internal orifice at the muscular level with 2-0 absorbable stitches of PDS and suture of the mucosal flap with 3-0 absorbable vycril sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed Crohn's disease
- presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
- The patient has received, understood and signed the informed consent to actively participate in the study.
- The patient is able to understand the conditions of the study and to participate for the whole duration.
Key exclusion criteria (6 listed)
- presence of oostomy
- Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
- Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
- Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
- Patients with active oncological or lymphoproliferative diseases
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 |
|---|---|---|
| Microfractured adipose tissue injection and plug placementAlso: Lipogems LGD 60 CND V0599 - RDM 1256088, Surgimend AWR 3X3 cm, 606-001-012 DM 409689/Rsurgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis | Device | Microfractured adipose tissue injection and plug placement, endoanal mucosa flap |
Primary outcome
combined remission
Time frame: 24 weeks
clinical (absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) and radiological (absence of abscesses > 3 mm) closure of the fistula
5 secondary outcomes
clinical remission
Time frame: 12, 16, 20, 24 weeks
clinical response
Time frame: 12, 16, 20, 24 weeks
failure
Time frame: 12, 16, 20, 24 weeks
IBDQ score (quality of life)
Time frame: 4, 8, 12, 16, 20, 24 weeks
Incidence of adverse events
Time frame: 4, 8, 12, 16, 20, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Silvio Laureti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfractured adipose tissue injection and plug placement in people with Rectovaginal Fistula and Crohn Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 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: paused, as of the sponsor's last update on 7 Feb 2025. 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?
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?
combined remission (time frame: 24 weeks). 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 7 Feb 2025.