Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fleet enema | Active Comparator | This group will receive Fleet enema as their treatment |
|
| TF037 | Experimental | This group will receive TF037 as their treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TF037 | Device |
| ||
| Fleet enema |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale | Between 1 to 3 hours following enema administration |
| Measure | Description | Time Frame |
|---|---|---|
| Stool output as measured by stool weight | To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema | up to 1 hour following enema administration |
| Safety and tolerability as assessed by use of a Visual Analogue scale (VAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronnie Beboso, MD | BioKinetic Europe Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioKinetic Europe Ltd | Belfast | Northern Ireland | BT2 7BA | United Kingdom | ||
| BioKinetic Europe Ltd |
Not provided
| ID | Term |
|---|---|
| C018279 | sodium phosphate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose |
| 5 and 30 minutes following enema administration |
| Stool output over time | To assess kinetics of bowel movements in relation to stool output over time | 1 hour following enema administration |
| Belfast |
| United Kingdom |