CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes
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..
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Crystal George
- 전화번호: 972-999-2070
- 이메일: crystal@clinqure.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tympanostomy Tube Treatment
Subjects undergoing myringotomy with tympanostomy tube placement
|
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 to assist the procedure.
Compared to manual techniques, the CLiKX device automates key steps, including creating a precise slit incision using regulated force.
This approach is designed to reduce operator variability, minimize trauma to the tympanic membrane, and improve accuracy of tube placement.
Clinicians retain full control over targeting throughout the procedure.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effectiveness of C-TTDS for tympanostomy tube placement
기간: At time of procedure (first or second attempt)
|
Effectiveness will be determined by success at the end of each ear tube procedure.
Effectiveness is defined as the successful incision in the tympanic membrane and delivery of tympanostomy tube across the tympanic membrane in the proper position after a maximum of 2 insertion attempts per indicated ear.
An insertion attempt is defined as an incision in the tympanic membrane by the C-TTDS
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At time of procedure (first or second attempt)
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Safety of C-TTDS for tympanostomy tube placement
기간: At time of procedure (first or second attempt)
|
Safety will be assessed by incidence, severity and relatedness of device related adverse events occurring during the overall procedure.
|
At time of procedure (first or second attempt)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
FLACC Pain Scale
기간: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
|
Face, Legs, Activity, Cry, and Consolability observational pain rating scalle for Infants and children less greater than or equal to 6 months to 5 years of age.
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≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
|
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FPS-R
기간: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
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Faces Pain Rating Scale - Revised self-reporting pain rating scale for children greater than or equal to 5 to 7 years of age
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≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
|
|
NRS Pain Scale
기간: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
|
11-point Number Rating Scale for Pain.
Provided to children, adolescents, and adults greater than or equal to 7 years of age
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≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
|
|
Caregiver Satisfaction Survey
기간: ≤ 1.0 hour after completion of the tympanostomy procedure
|
Procedure satisfaction and acceptability will be assessed using a subject-, parent-, guardian-, and/or caregiver-reported satisfaction survey evaluating procedure tolerability, satisfaction, perceived importance of alternatives to general anesthesia, perceived reduction in cost and procedure time, and willingness to recommend the procedure to others. Survey responses will be assessed using a 5-point Likert scale:
Higher scores indicate greater procedure satisfaction and acceptability. |
≤ 1.0 hour after completion of the tympanostomy procedure
|
|
Physician Procedure Tolerability Evaluation
기간: ≤ 1.0 hour after completion of the tympanostomy procedure
|
Performing surgeon and anesthesiologist acceptability of subject tolerability of the procedure.
Binary 'Yes' or 'No' response
|
≤ 1.0 hour after completion of the tympanostomy procedure
|
공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DDP-001-043P
- CKX-001 (기타 식별자: ClinQure, Inc.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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중이염에 대한 임상 시험
-
Umraniye Education and Research Hospital완전한
-
Muğla Sıtkı Koçman University완전한