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RF Ablation Device

RF Trigone Ablation Treatment Arm for Urinary Incontinence (TRANSFORM Trial)

N/A
Waitlist Available
Research Sponsored by Hologic, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing a device to treat urinary incontinence by zapping the trigone, an area in the bladder. Up to 325 people will be enrolled at 35 sites in the US, with some additional sites in other countries.

Eligible Conditions
  • Urinary Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint
Primary Safety Endpoint

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: RF Trigone Ablation Treatment ArmActive Control1 Intervention
A compatible standard cystoscopy lens (30°) will be inserted into the Hologic trigone RF Device. The bladder will be emptied of urine and saline infused into the bladder to allow adequate visualization and working space. Ablations at the trigone will be created using the Hologic trigone RF ablation device together with the compatible standard commercially available RF cannula and generator. It is expected that a subject would receive between 4-6 ablations to completely treat the appropriate area of the trigone. At the completion of the procedure, 200 ml of saline is instilled into the bladder to allow for assessment of voiding function prior to discharge.
Group II: RF Trigone Ablation Sham ArmPlacebo Group1 Intervention
The sham procedure will mimic the Hologic trigone RF ablation device procedure to maintain subject blinding and provide the most accurate assessment of control data while minimizing risk to the subject. The bladder will be emptied of urine and saline infused into the bladder to allow adequate visualization and working space. Suction will be applied to the bladder wall and the cannulas (needles) will be introduced into the bladder wall. Energy will not be delivered to the tissue when each sham "ablation" is started. In order to maintain blinding of the subject, the typical sounds that Hologic trigone RF ablation device makes during actual ablation/fulguration will be replicated. The simulated ablation procedure will be repeated as many times as necessary to cover the area of the trigone. 4 to 6 sham "ablations" would be required. At the completion of the procedure, 200ml of saline is instilled into the bladder to allow for assessment of voiding function prior to discharge.

Find a Location

Who is running the clinical trial?

NAMSAOTHER
49 Previous Clinical Trials
19,485 Total Patients Enrolled
Hologic, Inc.Lead Sponsor
46 Previous Clinical Trials
59,882 Total Patients Enrolled
~123 spots leftby Feb 2030
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