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

9 september 2026 bijgewerkt door: 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..

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40220
    • Texas
      • Mesquite, Texas, Verenigde Staten, 75150
        • Werving
        • Clinical Investigations of Texas
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Arun Badi, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Tympanostomy Tube Treatment
Subjects undergoing myringotomy with tympanostomy tube placement
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of C-TTDS for tympanostomy tube placement
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FLACC Pain Scale
Tijdsspanne: ≤ 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
Tijdsspanne: ≤ 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
Tijdsspanne: ≤ 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
Tijdsspanne: ≤ 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
Tijdsspanne: ≤ 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ClinQure, Inc.

Medewerkers

NousQ Pte Ltd

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 juli 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DDP-001-043P
  • CKX-001 (Andere identificatie: ClinQure, Inc.)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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