BAFIARS - Biomedical Assessment of Function and Imaging of the Ano-rectal Sphincter

NCT02778048 | Suspended DMC

• 1 other identifier: KEK BE 359/15
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary consortium consisting of representatives ranging from clinical medicine via microelectronics towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The aim of this campaign includes development of implantable prototype devices acting as artificial continence muscles using low-voltage electrically activated polymers (EAPs) controlled by implemented pressure sensors and the patient. Subsequently, the knowledge of the anatomical and biomechanical properties of the anal sphincter complex are of cardinal importance. Most of the existing data on anatomy and physiology results is based on old studies and almost no data on biomechanical properties are available. However, new technologies or even merging data from different examination methods might provide new information in this field.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (4)

• sphincter closing pressure [mmHG]

  at rest and during squeeze manoeuvres

  1 year

• sphincter muscle length [mm]

  1 year

• sphincter muscle thickness [mm]

  1 year

• sphincter compliance [mm/mmHG]

  The compliance is a measure used in medicine describing the elasticity of tissue. In the case of this study it describes the elasticity of the anal canal, the sphincter muscles respectively. The compliance is directly measured with the help of the functional lumen imaging probe (FLIP).

  1 year

Secondary Outcomes (1)

• Young's modulus of sphincter muscle (mmHG/mm2]

  1 year

Study Arms (1)

fecal incontinence patients (m/f)

patients suffering from fecal incontinence (m/f) are going to be assessed via MRI, US, FLIP, and HRAM

Other: MRI (magnetic resonance imaging); Other: US (ultra sound); Other: FLIP (functional lumen imaging probe); Other: HRAM (high resolution anal manometry)

Interventions

MRI (magnetic resonance imaging) OTHER

Assessment of the sphincter

fecal incontinence patients (m/f)

US (ultra sound) OTHER

Assessment of the sphincter

fecal incontinence patients (m/f)

FLIP (functional lumen imaging probe) OTHER

Assessment of the sphincter

fecal incontinence patients (m/f)

HRAM (high resolution anal manometry) OTHER

Assessment of the sphincter

fecal incontinence patients (m/f)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited by flyers and advertisement in internet.

You may qualify if:

• Informed Consent as documented by signature
• Wexner score \>= 12
• Longo's obstructed defecation syndrome (ODS) score =0
• MRI safety (no metallic implants. Appendix MRI safety form)
• Normal weighted (20\<BMI\<30)
• Age ≥ 60 years

You may not qualify if:

• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Nano-Tera.ch, Lausanne: collaborator
• Kantonsspital Winterthur KSW: collaborator
• University of Bern: collaborator
• University of Basel: collaborator

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Magnetic Resonance Spectroscopy; CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins

Study Officials

• Lukas Brügger, PD, Dr. med.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 19, 2016
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)