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出境医 / 临床实验 / Registry Evaluation of a Double Balloon Accessory Device
Registry Evaluation of a Double Balloon Accessory Device
Study Description
Brief Summary:
This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
| Condition or disease | Intervention/treatment |
|---|---|
| Adenomatous Polyp of Colon | Device: Double balloon accessory device |
Study Design
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 165 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 30 Days |
| Official Title: | Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine. |
| Actual Study Start Date : | January 22, 2019 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | March 31, 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Ability to perform the procedure safely and effectively with the study device. [ Time Frame: Intraoperatively ]Investigator answers yes or no
Secondary Outcome Measures :
- Time to reach target lesion [ Time Frame: Intraoperatively ]Time measurement in hours and minutes
- Time to remove lesion after intervention begins [ Time Frame: Intraoperatively ]Time measurement in hours and minutes
- Total time using study device during case [ Time Frame: Intraoperatively ]Time measurement in hours and minutes
- Total case time [ Time Frame: Intraoperatively ]Time measurement in hours and minutes
- Total defect closure time [ Time Frame: Intraoperatively ]Time measurement in hours and minutes
- User feedback on device performance [ Time Frame: Intraoperatively ]Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.
- Number of Study Subjects with Treatment Related Adverse Events [ Time Frame: Up to 30 days ]No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 3, 2019 | ||||||
| First Posted Date | May 8, 2019 | ||||||
| Last Update Posted Date | December 11, 2020 | ||||||
| Actual Study Start Date | January 22, 2019 | ||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Ability to perform the procedure safely and effectively with the study device. [ Time Frame: Intraoperatively ] Investigator answers yes or no
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Registry Evaluation of a Double Balloon Accessory Device | ||||||
| Official Title | Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine. | ||||||
| Brief Summary | This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 30 Days | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Investigator's practice | ||||||
| Condition | Adenomatous Polyp of Colon | ||||||
| Intervention | Device: Double balloon accessory device
Double balloon accessory device is used during the endoscopic polypectomy procedure
Other Name: DiLumen
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Active, not recruiting | ||||||
| Actual Enrollment |
165 | ||||||
| Original Estimated Enrollment |
200 | ||||||
| Estimated Study Completion Date | March 31, 2021 | ||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03942965 | ||||||
| Other Study ID Numbers | DD_20 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Lumendi, LLC | ||||||
| Study Sponsor | Lumendi, LLC | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Lumendi, LLC | ||||||
| Verification Date | December 2020 | ||||||
