CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes

Официальное название

A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes

Обзор

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

Подробное описание

This is a prospective, single-arm, multicenter study designed to evaluate the safety and effectiveness of the CLiKX device for the placement of tympanostomy tubes in pediatric and adult patients undergoing tympanostomy tube insertion for the treatment of chronic otitis media or other conditions requiring tympanostomy tube placement.

Eligible participants include children and adults ≥6 months of age who are scheduled to undergo tympanostomy tube insertion and have an ear canal diameter ≥4 mm.

The primary objective of the study is to evaluate procedural success (effectiveness), defined as successful incision of the tympanic membrane (myringotomy) and delivery of the tympanostomy tube into the intended position, while minimizing device-related adverse events during the procedure (safety).

Secondary objectives include the assessment of safety through 30 days post-procedure, as well as evaluation of procedural workflow and device performance.

Participants will complete study visits at the following time points: Baseline, Tympanostomy Procedure Visit, Post-Tympanostomy Procedure Visit (at discharge), and a 30-day Follow-Up Visit. Adverse events, concomitant medications, and procedural tolerability will be monitored throughout the study period.

This study is designed to support the intended use of the CLiKX device for performing myringotomy and facilitating delivery of tympanostomy tubes through the tympanic membrane in a clinical setting.

Вмешательства

• Устройство CLiKX® Tympanostomy Tube Delivery System
  The CLiKX device is an automated, sensor-optimized, partially reusable handheld surgical device used for tympanostomy tube placement. It consists of multiple components assembled before use and disassembled after the procedure. The device includes integrated, pre-programmed software that controls its mechanical actions. The software is locked, cannot be modified by users, and does not perform diagnostic or therapeutic decision-making. Instead, it provides visual cues and applies controlled force

Первичные конечные точки

• Effectiveness of C-TTDS for tympanostomy tube placement [Срок оценки: At time of procedure (first or second attempt)]
• Safety of C-TTDS for tympanostomy tube placement [Срок оценки: At time of procedure (first or second attempt)]

Вторичные конечные точки (5)

• FLACC Pain Scale [Срок оценки: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit]
• FPS-R [Срок оценки: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit]
• NRS Pain Scale [Срок оценки: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit]
• Caregiver Satisfaction Survey [Срок оценки: ≤ 1.0 hour after completion of the tympanostomy procedure]
• Physician Procedure Tolerability Evaluation [Срок оценки: ≤ 1.0 hour after completion of the tympanostomy procedure]

Критерии участия

Критерии включения

• Subject is scheduled to undergo tympanostomy tube insertion.
• Subject is ≥ 6 months old at the time of informed consent.
• Subject has an ear canal diameter of ≥ 4 mm.
• Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).

Критерии исключения

• Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.
• Subjects with known adverse reaction to anesthesia.
• Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
• Subjects with otitis externa.
• Subjects with active acute otitis media.
• Subjects with an ear canal diameter < 4 mm.
• Ear drums that are overly vertical or horizontal
• Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.
• Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.
• Subjects with suspected middle ear tumors or vascular lesions.
• Subjects diagnosed with acute sensorial hearing loss
• Subjects with a history of surgery involving the ear drum.
• Subjects with hemotympanum.
• Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Advanced ENT and Allergy, PLLC — Louisville
• Clinical Investigations of Texas — Mesquite

Идентификаторы

NCT: NCT07625657 · DDP-001-043P · CKX-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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