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

2026年9月9日 更新者：ClinQure, Inc.

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..

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Kentucky
      • Louisville、Kentucky、アメリカ、40220
        • 募集
        • Advanced ENT and Allergy, PLLC
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Steven Shotts, MD
    • Texas
      • Mesquite、Texas、アメリカ、75150
        • 募集
        • Clinical Investigations of Texas
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Arun Badi, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Subject is scheduled to undergo tympanostomy tube insertion.
  2. Subject is ≥ 6 months old at the time of informed consent.
  3. Subject has an ear canal diameter of ≥ 4 mm.
  4. 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:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Tympanostomy Tube Treatment
Subjects undergoing myringotomy with tympanostomy tube placement
デバイス：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 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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Effectiveness of C-TTDS for tympanostomy tube placement
時間枠：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
At time of procedure (first or second attempt)
Safety of C-TTDS for tympanostomy tube placement
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
FLACC Pain Scale
時間枠：≤ 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.
≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
FPS-R
時間枠：≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
Faces Pain Rating Scale - Revised self-reporting pain rating scale for children greater than or equal to 5 to 7 years of age
≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
NRS Pain Scale
時間枠：≤ 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
≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
Caregiver Satisfaction Survey
時間枠：≤ 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:

  1. = Strongly Disagree
  2. = Disagree
  3. = Neutral
  4. = Agree
  5. = Strongly Agree

Higher scores indicate greater procedure satisfaction and acceptability.
≤ 1.0 hour after completion of the tympanostomy procedure
Physician Procedure Tolerability Evaluation
時間枠：≤ 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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ClinQure, Inc.

協力者

NousQ Pte Ltd

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月7日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DDP-001-043P
  • CKX-001 (その他の識別子：ClinQure, Inc.)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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