Usability, Safety and Efficacy of AspivixTM

NCT04441333 | Completed

• 1 other identifier: Aspivix_IUD2019_Pilot
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up. AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber. The aim of our pilot study is to assess the usability, safety and efficacy of the device. Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding comparative study is registered separately.

Conditions

IUD Insertion

Outcome Measures

Primary Outcomes (1)

• Usability and efficacy from the practitioner's perspective: questionnaire

  The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.

  Right after the use of the device (right after the end of the procedure to insert the IUD).

Secondary Outcomes (8)

• Participant's reported pain: Visual Analogue Scale

  Before the procedure, during speculum insertion, during AspivixTM vacuum application, during application of cervical traction, during IUD insertion, during AspivixTM release, 5 minutes after the end of the procedure

• Assessment of patient's satisfaction: questionnaire

  Right after the use of the device (right after the end of the procedure to insert the IUD).

• The number of placement attempts before traction can be applied

  During the procedure to insert the IUD which should last less than 5 minutes.

• The number of spontaneous releases during traction

  During the procedure to insert the IUD which should last less than 5 minutes.

• Assessment of bleeding

  During the procedure to insert the IUD which should last less than 5 minutes.

Study Arms (1)

AspivixTM cervical vacuum tenaculum

EXPERIMENTAL

Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum.

Device: AspivixTM cervical vacuum tenaculum

Interventions

AspivixTM cervical vacuum tenaculum DEVICE

Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum

AspivixTM cervical vacuum tenaculum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants older than 18 years
• Participants presenting at the outpatient clinic for Mirena IUD insertion.
• Participants able to provide informed consent as documented by signature with at least 24 hours of reflection time
• Good understanding of written and oral speaking used at the centre where the study will be carried out.

You may not qualify if:

• Participants who are contraindicated for the insertion of the IUD Mirena
• Participants under use of excessive alcohol, narcotics or benzodiazepines prior to procedure
• Participants who do not wish to be informed of a chance discovery
• Participant receiving anaesthetics prior to IUD insertion procedure
• Participants on anticoagulant medication
• Participants under use of an analgesic
• Previous cervical operation
• Severe vaginal bleeding
• Participant previously enrolled in this study
• Cervix diameter smaller than 26 mm
• Mullerian anomalies with two cervices
• Nabothian cyst
• Cervical myomas
• Cervical condylomas
• Squamous intraepithelial lesion (Cervical dysplasia)

Sponsors & Collaborators

• Aspivix SA: lead

Study Sites (1)

Department Women, Mother & Child, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Legardeur H, Masiello-Fonjallaz G, Jacot-Guillarmod M, Mathevet P. Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study. Front Med (Lausanne). 2021 Dec 23;8:742182. doi: 10.3389/fmed.2021.742182. eCollection 2021.

  PMID: 35004719 DERIVED

Study Officials

• Patrice Mathevet, Prof.

  DFME CHUV Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot study: single-arm non-comparative study

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)