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OpenTrials
Completed

NCT Number: NCT01862601

JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers

This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guy's Hospital / Quintiles, Ltd., London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.

Exclusion criteria

  • Unable or unwilling to sign Informed Consent Form or comply with study requirements
  • Non-English speaking
  • Currently enrolled in another clinical trial
  • Undergone treatments given into the bladder in the past 4 weeks
  • Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
  • Female subject and is currently breast feeding
  • Female subject and has given birth in past 6 months
  • Current or history of chronic urinary tract infections
  • Current or history of chronic hematuria
  • Current or history of bladder cancer
  • History of major surgery in the last 6 months
  • Current or history of bleeding disorders
  • Currently taking anticoagulants
  • Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
  • Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
  • Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
  • Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
  • Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
  • Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.

Treatment and study plan

JetTouch Needle-free injection system

Device

Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.

Primary outcomes

  1. Safety of the JetTouch system to deliver saline into the bladder wall.

    Time frame: within 14 days of the JetTouch procedure

  2. Ability of the JetTouch system to deliver saline into the bladder wall.

    Time frame: At the JetTouch procedure

Secondary outcomes

  1. Physician feedback on the use of the JetTouch system.

    Time frame: At the JetTouch Procedure

  2. Physician feedback on perceived subject tolerability of the JetTouch injection procedure.

    Time frame: At the JetTouch procedure.

  3. Subject feedback question regarding the procedure.

    Time frame: At the JetTouch procedure

Sponsors and collaborators

Lead sponsor

American Medical Systems

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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