on-invasive medical device for the treatment of chronic constipation: 1. Proof of Principle study in children.

Phase 2

• Conditions: Chronic Constipation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001643460
• Lead Sponsor: GI therapies Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients aged between 4 and 18 with chronic functional idiopathic constipation as defined by a > 6 month history of:
*Less than or equal to two spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment and
*At least 25% of the time suffer from at least one symptom of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation, or sensation of anorectal obstruction/blockage.

Exclusion Criteria

*Constipation secondary to endocrine causes, metabolic causes or neurological conditions
*Known or suspected organic disorders of the large bowel
*Serious chronic medical condition
*Surgical procedure on the large bowel or rectum
*Pregnancy or planning to become pregnant
*Insufficient comprehension of English requiring a translator
*Implanted cardiac defibrillator or pacemaker

Study & Design

• Study Type: Interventional
• Study Design: Not specified