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

• Sponsor: American Medical Systems (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01862601
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Duration (Months): 5.9
• Patients Per Site: 10
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Device: JetTouch Needle-free injection system	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JetTouch injections	Device: JetTouch Needle-free injection system; Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.

Outcome Measures

Primary Outcome Measures

1. Safety of the JetTouch system to deliver saline into the bladder wall. [within 14 days of the JetTouch procedure]

2. Ability of the JetTouch system to deliver saline into the bladder wall. [At the JetTouch procedure]

Secondary Outcome Measures

1. Physician feedback on the use of the JetTouch system. [At the JetTouch Procedure]

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

3. Subject feedback question regarding the procedure. [At the JetTouch procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's Hospital / Quintiles, Ltd.	London		United Kingdom	SE1 9RT
2	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield		United Kingdom

Sponsors and Collaborators

• American Medical Systems
• Quintiles, Inc.

Investigators

• Principal Investigator: Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU, Consultant Urological Surgeon, Royal Hallamshire Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: American Medical Systems
• ClinicalTrials.gov Identifier: NCT01862601
• Other Study ID Numbers: OT1202
• First Posted: May 24, 2013
• Last Update Posted: Jun 2, 2014
• Last Verified: May 1, 2014

Study Results

No Results Posted as of Jun 2, 2014