This study is a PMCF, sequential, non-interventional, prospective (follow-up: 30 ± 15 days), single-arm, single center, open trial.
Note: The design of this study is identical to the one of the Rx pre-market investigation (same design, same endpoints, same investigation site, same follow-up).
78 patients have been included in the pre-market investigation and will be used as part of dataset of the current PMCF study.
Sample size calculation (Wilson Method):
Considering the design of this study is identical to the one of the Rx pre-market investigation and that 78 patients have already been included in that pre-market clinical investigation (NCT05141370);
Assuming a rate of capsule-ruptures due to Rx \< 2%;
And an upper limit ≤ 3.5%;
The maximum number of patients to be included will be 446 patients (considering 78 patients have already been included, 368 remain to be included), corresponding to 8 capsular ruptures and a rate of 1.79% with an interval of \[0.91% ;3.5%\].
The investigator proposes to conduct a sequential study in which the number of patients depends on a success criterion and a failure criterion as detailed below.
As the study is sequential, interim analyses at the end of each sequence are planned to examine whether the objective of an upper limit of rupture rate ≤3.5% (success) is achieved, or whether the rupture rate equals or exceeds 2% (failure).
The study stops as soon as a success or failure criterion is verified.
Sequence 1:
\- 106 patients to reach:
* Success: 0 capsular rupture -\> superior limit ≤ 3.5%
* Failure: ≥ 3 capsular ruptures -\> a rupture rate ≥ 2%
If 1 ≤ number of capsular ruptures ≤2 the trial continues
Sequence 2:
\- 158 patients to reach:
* Success: 1 capsular rupture -\> superior limit ≤ 3.5%
* Failure: ≥ 4 capsular ruptures -\> a rupture rate ≥ 2%
If 2 ≤ number of capsular ruptures ≤3 the trial continues
Sequence 3:
\- 205 patients to reach:
* Success: 2 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 5 capsular ruptures -\> a rupture rate ≥ 2%
If 3 ≤ number of capsular ruptures ≤4 the trial continues
Sequence 4:
* 248 patients to reach:
* Success: 3 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 5 capsular ruptures -\> a rupture rate ≥ 2%
If 4 capsular ruptures the trial continues
Sequence 5:
\- 290 patients to reach:
* Success: 4 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 6 capsular ruptures -\> a rupture rate ≥ 2%
If 5 capsular ruptures the trial continues
Sequence 6:
\- 330 patients to reach:
* Success: 5 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 7 capsular ruptures -\> a rupture rate ≥ 2%
If 6 capsular ruptures the trial continues
Sequence 7:
\- 370 patients to reach:
* Success: 6 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 8 capsular ruptures -\> a rupture rate ≥ 2%
If 7 capsular ruptures the trial continues
Sequence 8:
\- 408 patients to reach:
* Success: 7 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 9 capsular ruptures -\> a rupture rate ≥ 2%
If 8 capsular ruptures the trial continues
Sequence 9:
* 446 patients to reach:
* Success: 8 capsular ruptures -\> superior limit ≤ 3.5%
* Failure: ≥ 9 capsular ruptures -\> a rupture rate ≥ 2%
446 patients is the maximum number of patients to be included in the study, as no condition other than success or failure can be verified.
