The CLiKX® Study
Tahapan Penelitian : Recruit
Sponsor:
NousQ Pte Ltd
73 Ayer Rajah Crescent, #02-25 JTC LaunchPad @ One-North, Singapore 139952.
Mitra Pelaksana:
Not Specified
No Registry
INA-KXZA5P2
Tanggal Input Registry : 04-12-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 27-05-2024 |
| Outcome Primer | Performance: To demonstrate successful placement of the tympanostomy tube across the eardrums using the CLiKX® tympanostomy Tube Delivery system. |
| Outcome Skunder | Safety: (a)To demonstrate the safety of the use of the CLiKX® tympanostomy Tube Delivery system procedure. (b)To evaluate number of attempts per patient before reaching a successful placement of the grommet using the CLiKX® tympanostomy Tube Delivery system. |
| Descriptive Information | |
| Judul Penelitian Popular | The CLiKX® Study |
| Judul Penelitian Ilmiah | A Prospective, Single-Site, Open-Label, Single-Arm, Non-Randomized, Clinical Investigation to Confirm the Safety and Performance of the CLiKX® Tympanostomy Tube Delivery System |
| Jenis Penelitian | Interventional |
| Intervensi | Grommet insertion using CLiKX® Tympanostomy Tube Delivery System |
| Jumlah Subyek Penelitian | 38 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Subjects who are aged between 1 to 75 years old, Subjects and/or parent(s) who are able to provide a written informed consent prior to participating in the clinical investigation, Conditions that require or indicated for tympanostomy tube placement across the eardrum, Behavior of subjects who, based on doctor’s judgement, are deemed capable of cooperating or complying with instructions for the procedure, Subject and/or parent of subject isou willing to comply with pre-surgical, intraoperative and post-surgical instructions, monitoring and follow up requirements.Exclusion Criteria: Patients with atrophic, dimeric or atelectatic eardrums,Patients with very thickened ear drums, Patients with soft tissue or tumor in the middle ear, Ear canal condition that is too tortuous or narrow to provide sufficient visualization or access the targeted quadrant of the eardrum, Eardrum that is near the horizontal or vertical plane, Conditions that require insertion of T-shape tube, Patients diagnosed with acute sensorineural hearing loss, Previous tube placement less than a year ago, Bleeding disorder or on blood thinning medications that cannot be discontinued for the surgery, Unable to or at high risk for any type of anesthesia, Pregnant women. |
| Administrative Information | |
| Nomor Persetujuan Etik | 1164/UN6.KEP/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | CX-CDP-CIP-CLiKX®(Beta-1) |
| Contact Person | Gan Chee Wee |