| INA-KXZA5P2 |
| 05-12-2024 |
| 04-12-2024 |
| Yes |
| Protocol Number |
| CX-CDP-CIP-CLiKX®(Beta-1) |
| 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 |
| The CLiKX® Study |
| |
| NousQ Pte Ltd
73 Ayer Rajah Crescent, #02-25 JTC LaunchPad @ One-North, Singapore 139952. |
| NousQ Pte Ltd
73 Ayer Rajah Crescent, #02-25 JTC LaunchPad @ One-North, Singapore 139952. |
| Not Specified |
| |
| Dr. Sally Mahdiani., Sp.THTBKL, Subsp.Oto(K), M.Kes |
| Bandung |
| Indonesia |
| Fakultas Kedokteran Universitas Padjadjaran (UNPAD) |
| sally.mahdiani@gmail.com |
| Gan Chee Wee |
| NousQ Pte Ltd
73 Ayer Rajah Crescent, #02-25 JTC LaunchPad @ One-North, Singapore 139952. |
| Singapore |
| Singapore |
| 139952 |
| Chief Technical Officer – NousQ Pte Ltd |
| cheewee@clikxmed.com |
| +69575880 |
| Dr. Sally Mahdiani., Sp.THTBKL, Subsp.Oto(K), M.Kes. |
| Faculty of Medicince Universitas Padjajaran (UNPAD)
Jl. Prof. Eijkman No. 38 Bandung, Indonesia 40161 |
| Bandung |
| Indonesia |
| 40161 |
| Principal Investigator |
| sally.mahdiani@gmail.com |
| |
| 1164/UN6.KEP/EC/2024 |
| Komite Etik Penelitian Universitas Padjajaran |
| 07-11-2024 |
| Komite Etik Penelitian (Research Ethics Committee) Universitas Padjajaran
Jl. Prof. Eyckman No. 38 Bandung 40161
Telp. & Fax. 022-2038697
email: kep@unpad.ac.id,
website: kep.unpad.ac.id |
| FH. 03.03/E/2359/2024, tanggal 18 November 2024 |
| |
| Indonesia |
| Rumah Sakit Ibu Anak (RSIA) Limijati, Bandung, Jawa Barat |
| Recruit |
| 27-05-2024 |
| 00038 - |
| 23 |
|
| |
| All conditions that require installation of a ventilation pipe in the Eardrum |
| Treatment |
| Interventional |
| Clinical trial |
| Phase 3 |
| Not Applicable (single arm study) |
|
| No (open) |
| Grommet insertion using CLiKX® Tympanostomy Tube Delivery System |
| No Treatment |
| Single arm |
| |
| Not specified |
| 1 |
| 75 |
| 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. |
| 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. |
| |
| Performance:
To demonstrate successful placement of the tympanostomy tube across the eardrums using the CLiKX® tympanostomy Tube Delivery system. |
| Number of successful placements of the tympanostomy tube across the eardrums using the CLiKX® tympanostomy Tube Delivery system.
A maximum of 2 full incisions on the ear drums are allowed. Beyond this point, the patient should be converted to standard instruments for placing the tube and the primary endpoint will not be met for this matter. |
| During the procedure of Grommet insertion using CLiKX® Tympanostomy Tube Delivery System |
| 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. |
| Safety
(i)Percentage of adverse device effects with specific focus on:
(1)The rate of inadvertent over-insertion into the middle ear space.
(2)Acoustic trauma (postoperative hearing threshold worse than preoperative hearing threshold).
Definition: no more than 15 dB air conduction pure tone average (PTA) change from baseline at 1-week follow-up.
(3)The rate of unintended tympanic membrane perforation requiring additional intervention if it does not heal in 8 weeks.
(ii) Occurrence of any non-device/procedure related events from screening start to last follow up.
(iii) Number of attempts per patient before to reach a successful placement of the grommet using the CLiKX® tympanostomy Tube Delivery system. |
| During the procedure of Grommet insertion using CLiKX® Tympanostomy Tube Delivery System and Follow up visit on 1 week and 1 month after the procedure |
| Performance/Effectiveness:
(a) User handling
To evaluate the ease of use of the CLiKX® tympanostomy Tube Delivery system during tympanostomy tube placement procedure.
(b) Mode of visualization
To observe the procedure performance systematically using the headlight with magnification instead of the usual microscope/endoscope.
(c) Mode of anesthesia
To observe the preference of anesthesia mode: performing procedure under general anesthesia, moderate sedation with topical anesthesia or with topical anesthesia alone.
(d) Tube retention
To evaluate the duration of tube retention at 1 week and 1 month. |
| Performance
(i) Mode of Visualization
Number and profile (age, ethnicity, and ear canal size) of subjects that can accommodate:
(1) Successful visualization of the suture at the shaft tip of CLiKX® on the ear drum.
(2) Successful insertion of the tube with headlight with magnification visualization, without needing the microscope/endoscope
The surgeon will use the headlight with magnification to visualize the ear drum after the grommet tube has been placed on the ear drum. The surgeon will document if he is able to visualize the ear drum well and see the deflection of the proximity suture attached to the tip of the shaft of CLiKX® on the ear drum.
The surgeon may also use the headlight with magnification to place the grommet with CLiKX® if surgeon is confident that the headlight with magnification is feasible for visualization, in place of the microscope/endoscope. Otherwise, microscope/endoscope will be used.
(ii) Mode of Anesthesia
Number and profile (age, ethnicity, and ear canal size) of subjects that had successful vs unsuccessful tube insertions with CLiKX® under general anesthesia, moderate anesthesia with topical anesthesia, and topical anesthesia alone.
The first one or two pediatric subjects of each investigator(s) will receive general anesthesia (GA). Up to the usual 2 full slit incisions can be made in the ear drum with CLiKX®. If an unsuccessful insertion with CLiKX® (with 2 full incisions or when there is not possible to make 2nd incision after the first one fails to insert the grommet tube), the insertion will be performed with the use of standard multiple instrumentation.
Depending on the patient’s compliance as per investigator’s assessment, the moderate sedation with topical anaesthesia or with topical anaesthesia alone will be the mode of anaesthesia. If required, the general anaesthesia shall also still be chosen.
(iii) Tube Retention:
Percentage of tube retention at 1-week and 1-month.
(iv) User Handling
Assessment of user handling including the ease of tube insertion during surgery, with the use of investigators questionnaires. |
| During the procedure of Grommet insertion using CLiKX® Tympanostomy Tube Delivery System and Follow up visit on 1 week and 1 month after the procedure |
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| Not Specified |
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| Undecided |
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| Not Specified |
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