免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Patent Foramen Ovale Closure Reduce in SCUBA-divers
Patent Foramen Ovale Closure Reduce in SCUBA-divers
Study Description
Brief Summary:
It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).
| Condition or disease | Intervention/treatment |
|---|---|
| Patent Foramen Ovale Decompression Illness | Other: phone interviews |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 9 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Patent Foramen Ovale Closure Reduce in SCUBA-divers |
| Actual Study Start Date : | January 1, 2017 |
| Actual Primary Completion Date : | May 1, 2019 |
| Actual Study Completion Date : | May 1, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Dives [ Time Frame: 2017-01-01 until 2019-01-01 ]Interview based on a questionnaire with questions focusing on the dive habits and DCI events.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 20, 2019 | ||||
| First Posted Date | June 25, 2019 | ||||
| Last Update Posted Date | June 25, 2019 | ||||
| Actual Study Start Date | January 1, 2017 | ||||
| Actual Primary Completion Date | May 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Dives [ Time Frame: 2017-01-01 until 2019-01-01 ] Interview based on a questionnaire with questions focusing on the dive habits and DCI events.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Patent Foramen Ovale Closure Reduce in SCUBA-divers | ||||
| Official Title | Patent Foramen Ovale Closure Reduce in SCUBA-divers | ||||
| Brief Summary | It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO). | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | all Swedish patients who had had catheter-based PFO-closure | ||||
| Condition |
|
||||
| Intervention | Other: phone interviews
phone interviews
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
9 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | May 1, 2019 | ||||
| Actual Primary Completion Date | May 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: - |
||||
| Sex/Gender |
|
||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03997084 | ||||
| Other Study ID Numbers | 2017-01-01 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Joanna Hlebowicz, Skane University Hospital | ||||
| Study Sponsor | Skane University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Skane University Hospital | ||||
| Verification Date | June 2019 | ||||
