Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 11:04 AM
Study NCT ID:
NCT03922906
Status:
TERMINATED
Last Update Posted:
2021-02-25
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Sponsor:
Motus GI Medical Technologies Ltd
Organization:
Study Overview
Official Title:
Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped due to COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.
Detailed Description:
The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.
Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: