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Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study

NCT02263170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2015-11-24

No results posted yet for this study

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

Interventions

OTHER

MRI (magnetic resonance imaging)

Assessment of the sphincter morphology

OTHER

US (ultra sound)

Assessment of the sphincter morphology

OTHER

FLIP (functional luminal imaging probe)

Assessment of the biomechanical properties of the sphincter region

OTHER

HRAM (high resolution anal manometry)

Assessment of the biomechanical properties of the sphincter region

Sponsors & Collaborators

  • Nano-Tera.ch, Lausanne

    collaborator UNKNOWN

  • Spitäler Schaffhausen

    collaborator UNKNOWN

  • University of Bern

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Bert Müller, Prof. Dr. · Biomaterials Science Center (BMC) University of Basel c/o University Hospital Basel 4031 Basel

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263170 on ClinicalTrials.gov