Performance of the TransiCap device as a method for obtaining whole gut transit time in Patients (Age-7 years old and above) with Chronic Constipation. Digestive System
Conditions
Interventions
This study is a Pre-market, Pivotal confirmatory clinical investigation of a medical device. Single arm, unblinded, multi-centre, case series.
The research team have invented a new method to measure
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
7 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 7 years old and above 2. Having a clinical diagnosis of CC, defined broadly as characterised by stools that are infrequent and/or difficult to pass in the absence of mucosal/structural abnormalities. 3. Having had a transit study (either X-ray or gamma scintigraphy) organised within 6 months of the TransiCap test and carried out according to the local site standard procedures 4. Willing to consent for participation in the clinical investigation or, if below 16 years of age, willing to give assent for participation in the clinical investigation and have a parent/carer willing to give informed consent for participation in the clinical investigation. 5. Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation.
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported. 2. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as cholecystectomy, colectomy or small bowel resection. 3. Existing antegrade colonic enema (ACE) procedure. 4. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury. 5. Inability to lie flat and relatively still for less than 5 minutes. 6. Poor ability to understand instructions or the consent process 7. Difficulties in swallowing tablets, dysphagia or a diagnosis of oesophageal dysmotility 8. The following disease or disorder: an active eating disorder (e.g. anorexia), known presence of bowel strictures, inflammatory bowel diseases, Hirschsprung disease, congenital anorectal malformations, Chronic Intestinal pseudo-obstruction. 9. Unable or unwilling to temporarily discontinue for the duration of the study drugs influencing gut function such as: laxatives, anticholinergics, prokinetics, opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramol); antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide 10. Participation in another research clinical investigation involving an investigational product in the past 12 weeks
Countries
England, United Kingdom
Contacts
Public ContactSoham Mukherjee
Outcome results
None listed