BridgeMD
FI-3, Fidelia
EU CTIS ID: 2024-518243-38-00
What this study is testing
The primary objective of this study is the final assessment of clinical efficacy and clinical safety of ICEF15 therapy for patients with fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part 1 General: Patients of ≥18 years of age
- Patients willing and able to comply with the study procedures
- Patients who are mentally competent and able to understand all study requirements
- Patients must agree to read and sign the Informed Consent (IC) form prior to any studyrelated procedures
- Female patients of childbearing potential willing to use appropriate methods of contraception (see Section 8.4.6.3). Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.
- Part 2 Related to fecal incontinence: At Screening (V1), the patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months but equal to or less than 10 years, and did not improve sufficiently by conservative treatment performed for at least 3 months
You likely can't join if
- Part 1 General: Patients who, according to the clinical judgment of the investigator, are not suitable for this study
- Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures
- Patients with poorly controlled chronic constipation including obstructed defecation syndrome
- Part 3 Biopsy/Implantation-specific: Patients with indications against a surgery under anesthesia
- Part 4 Cell therapy-specific: Patients with a malignant disease not in remission for 5 years or more
- Patients who have undergone radiation therapy of the bowel and pelvis
See the full eligibility criteria
Who can join
- Part 1 General: Patients of ≥18 years of age
- Patients willing and able to comply with the study procedures
- Patients who are mentally competent and able to understand all study requirements
- Patients must agree to read and sign the Informed Consent (IC) form prior to any studyrelated procedures
- Female patients of childbearing potential willing to use appropriate methods of contraception (see Section 8.4.6.3). Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.
- Part 2 Related to fecal incontinence: At Screening (V1), the patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months but equal to or less than 10 years, and did not improve sufficiently by conservative treatment performed for at least 3 months
- Urge fecal incontinence episodes exceeding ”traces” (as defined by the patient’s diary) that occur more than twice a week
- Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry of 100 mmHg or less in women and 150 mmHg or less in men
- Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees
What rules you out
- Part 1 General: Patients who, according to the clinical judgment of the investigator, are not suitable for this study
- Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures
- Patients with poorly controlled chronic constipation including obstructed defecation syndrome
- Part 3 Biopsy/Implantation-specific: Patients with indications against a surgery under anesthesia
- Part 4 Cell therapy-specific: Patients with a malignant disease not in remission for 5 years or more
- Patients who have undergone radiation therapy of the bowel and pelvis
- Patients who have undergone chemotherapy within the last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
- Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
- Patients with a diagnosis of chronic inflammatory bowel disease (e.g. Crohn’s disease, Colitis Ulcerosa)
- Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons
- Patients with known hypersensitivity to any component of the product (autologous cells, Ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor (FGF), gentamicin)
- Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency situation
- Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic Hepatitis- C-virus (HCV), acute or chronic Hepatitis-B-virus (HBV), active Syphilis or Human Tlymphotropic virus (HTLV) (HTLV tested upon risk assessment by investigator)
- Patients diagnosed with any kind of skeletal muscle-disease and/or neuronal disorders
- Part 5 Related to electrical stimulation: Patients with severe myocardial disorders, irregular pulse or a pacemaker
- Patients with implantations of metal components in the electrical stimulation treatment area
- Defects of the skin and mucous membranes (injuries, ulcerations) and acute inflammation of the mucous membranes, skin or subcutaneous tissue in the treatment area
- Metal implants in the field of treatment
- Bleeding in the treatment area
- Known mental illnesses, cognitive disorders
- Part 6 Other: Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
- Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment
- Patients who are currently participating or have participated in another clinical study (testing a medical device or drug) within 30 days prior to screening Visit 1 in this study or have previously participated in this study
- Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.)
- Female patients who are pregnant, lactating, or intending pregnancy in the study and female patients of childbearing potential who are not willing to use appropriate methods of contraception (see Section 8.4.6.3) up to Visit 8. or who have a positive pregnancy test (only to be performed in women of childbearing potential)
- Part 2 Related to fecal incontinence: Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. This evaluation is based on the current medical history, surgical history physical examination, anoscopy / rectoscopy, anorectal manometry, and anal canal ultrasonography at the screening visit (V1) As specific exclusion: • Patients with chronic diarrhea or liquid stool that my cause fecal incontinence • Patients with rectal fecal impaction that may be the cause of overflow fecal incontinence • Patients who may have passive fecal incontinence due to rectal hyposensitivity and lack of urge to defecate • Patients in whom the cause of fecal incontinence is considered to be or cannot be excluded to be neuropathy or myelopathy • Patients with Goligher class III internal hemorrhoids (patients with Goligher class I and class II internal hemorrhoids are not excluded as they are considered not clinically involved in fecal incontinence)
- Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound
- Patients who underwent any anorectal surgery within 6 months before screening visit
- Patients who underwent a total of two or more external anal sphincter-related surgeries (only one repair after an obstetric injury after vaginal birth is allowed)
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.