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NCT06193590 · ClinicalTrials.gov registry record · NA

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
73
Enrollment target

NCT06193590: Completed NA study, sponsored by Indiana University.

NCT06193590 is a NA study that has completed, run by Indiana University. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06193590, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
73 participants
Enrollment target

Study Summary

To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.

Primary Outcome

Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.

Interventions

  • DEVICE Carevix
  • DEVICE Tenaculum

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2023-11-09
Est. Completion 2024-04-15
Phase NA
Indiana University

890 total trials

What the finished NCT06193590 record still lists

NCT06193590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Carevix is the first listed.

NCT06193590 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06193590 about?

NCT06193590 is a clinical study titled "Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures". To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by ...

What is the current status of trial NCT06193590?

This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2023-11-09. Estimated completion is 2024-04-15.

What interventions are being tested in trial NCT06193590?

The interventions under investigation include: Carevix (DEVICE), Tenaculum (DEVICE).

Who is sponsoring clinical trial NCT06193590?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06193590's enrollment target sits among peer trials

73 1089th of 2000 higher than 912 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06193590, the US trial registry maintained by the National Library of Medicine. NCT06193590 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.