Usability, Safety and Efficacy of AspivixTM (Comparative Study)

Aspivix

Status: Completed

Conditions: IUD Insertion

Treatments: Procedure: Traction of the cervix for IUD insertion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04441281

Aspivix_IUD2019_Comparative

Details and patient eligibility

About

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 comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).

Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding pilot study is registered separately.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants older than 18 years
• Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
• 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.

Exclusion criteria

• Participants who are contraindicated for the insertion of the IUD Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
• 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 (< 12 hours)
• Previous cervical operation
• Severe vaginal bleeding of unknown origin
• Participant previously enrolled in this study
• Cervix diameter smaller than 26 mm
• Nabothian cyst
• Cervical myomas
• Cervical condylomas
• Squamous intraepithelial lesion (Cervical dysplasia)
• Cervical endometriosis
• Cervical tears
• A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
• Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
• Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
• Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Single-tooth tenaculum (Pozzi forceps)

Active Comparator group

Description:

In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix.

Treatment:

Procedure: Traction of the cervix for IUD insertion

AspivixTM cervical vacuum tenaculum

Experimental group

Description:

In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix.

Treatment:

Procedure: Traction of the cervix for IUD insertion