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IUD Removal Techniques for Intrauterine Device Removal

N/A

Recruiting

Led By Cara Clure, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-18 months

Awards & highlights

Study Summary

This trial will compare two methods of removing IUDs with missing strings and measure patient/provider satisfaction, pain, time, and complications. Results may improve access and expand options for IUD removal.

Who is the study for?

This trial is for women aged 18-45 who want their IUD removed but can't see the strings. They must have a confirmed intrauterine IUD by ultrasound. Pregnant women, those with visible IUD strings, or anyone unwilling to be randomly assigned to a removal technique cannot participate.Check my eligibility

What is being tested?

The study compares two techniques for removing IUDs without visible strings: using alligator forceps or manual vacuum aspiration (MVA). It aims to determine which method has higher success rates and gather data on patient/provider satisfaction, pain levels, time taken, and any complications.See study design

What are the potential side effects?

Potential side effects from the procedures may include discomfort or pain during removal, possible injury to the uterus or cervix, bleeding, infection risk post-procedure, and emotional distress if complications occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

First-pass IUD removal rates

Secondary outcome measures

Overall IUD removal success rates

Other outcome measures

Preliminary data on complications

Preliminary data on pain scores

Preliminary data on procedure time

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Removal with manual vacuum aspirationExperimental Treatment2 Interventions

Intrauterine placement of an MVA under ultrasound guidance adjacent to the IUD to remove the IUD. Multiple attempts will be performed up to a maximum of 3 unsuccessful MVA attempts, after which time, the provider will switch to the alligator forceps technique, given that this is the current standard of care.

Group II: Removal with alligator forcepsExperimental Treatment2 Interventions

Standard of care removal with passage of an intrauterine alligator forceps under ultrasound guidance to grasp and remove the IUD. If required, multiple attempts will be performed using this technique.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alligator forceps

2015

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,451 Total Patients Enrolled

Cara Clure, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

IUD removal with no visible strings Clinical Trial Eligibility Overview. Trial Name: NCT05702242 — N/A

Intrauterine Device Research Study Groups: Removal with alligator forceps, Removal with manual vacuum aspiration

Intrauterine Device Clinical Trial 2023: IUD removal with no visible strings Highlights & Side Effects. Trial Name: NCT05702242 — N/A

IUD removal with no visible strings 2023 Treatment Timeline for Medical Study. Trial Name: NCT05702242 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians permitted to apply for this research experiment?

"Based on the given conditions, individuals between 18 and 45 years old may be eligible to participate in this trial."

Answered by AI

Are new participants being accepted to take part in this trial?

"The clinical trial database lists this study as actively searching for participants. The initial post date was January 1, 2023 with the most recent update on January 17th of that same year."

Answered by AI

What criteria must be met in order to participate in this research program?

"Qualifying candidates for this clinical investigation must demonstrate non-detectable intrauterine device threads and be within the ages of 18 to 45. A total of 75 patients are expected to take part in this trial."

Answered by AI

How many participants are partaking in this research?

"Affirmative. According to the details provided on clinicaltrials.gov, this trial is actively enrolling participants from one site since it was first published in January 1st 2023 and last updated on January 17th 2023. A total of 75 people are needed for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques

2023. "A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05702242.