Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement

NCT06813768 | Suspended DMC

• 1 other identifier: LIPOPLUG - CROHN
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

Conditions

Rectovaginal Fistula; Crohn Disease

Keywords

MICROFTACTURED ADIPOSE TISSUE; BIOLOGIC MESH; ENDOANAL FLAP; LIPOSUCTION

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Secondary Outcomes (5)

• clinical remission

  12, 16, 20, 24 weeks

• clinical response

  12, 16, 20, 24 weeks

• failure

  12, 16, 20, 24 weeks

• IBDQ score (quality of life)

  4, 8, 12, 16, 20, 24 weeks

• Incidence of adverse events

  4, 8, 12, 16, 20, 24 weeks

Study Arms (2)

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

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.

Device: Microfractured adipose tissue injection and plug placement

Interventions

Microfractured adipose tissue injection and plug placement DEVICE

surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis

Also known as: Lipogems LGD 60 CND V0599 - RDM 1256088, Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R

Microfractured adipose tissue injection and plug placement; endoanal mucosa flap

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with recto-vaginal fistulas
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Rectovaginal Fistula; Crohn Disease

Condition Hierarchy (Ancestors)

Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• Silvio Laureti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization procedures and statistical analyses will be performed by an investigator not involved in the clinical evaluation or surgical treatment of patients. All clinical evaluations will be performed by independent co-investigators not involved in the surgical procedures and blinded to patient assignment. The dedicated radiologist who will evaluate the MRI scans will be blind to patient allocation. Surgeons will not be able to share information about the treatment used in the surgical procedure and will not be able to participate in any clinical evaluation of the MPC during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: January 7, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-12

Locations

IT (1)