Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy (NCT NCT00462124)

Results Overview

Assessed by collecting number of subjects experiencing a serious device related adverse event.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2019-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Implant Absorbable perirectal spacer implantation
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Implant n=7 Participants Implantation of a biodegradable balloon spacer (absorbable perirectal spacer) to increase the distance between prostate and anterior rectal wali.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Age, Continuous	70 years STANDARD_DEVIATION 6 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment Israel	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT

Assessed by collecting number of subjects experiencing a serious device related adverse event.

Outcome measures

Outcome measures
Measure	Balloon Implant n=7 Participants Absorbable perirectal spacer implantation
Safety of Balloon Implant	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT

The space between the prostate and the rectum will be determined by Ct in subjects with prostate cancer who underwent radiotherapy and who received the balloon. The degree of increase in this space is directly related to a reduction of isodose level delivered to the rectum, and therefore a reduction in post radiation therapy rectal adverse event sequela.

Outcome measures

Outcome measures
Measure	Balloon Implant n=7 Participants Absorbable perirectal spacer implantation
Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum	7 Participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=7 participants at risk Absorbable perirectal spacer implantation
Gastrointestinal disorders Tear in rectal mucosa	14.3% 1/7 • Number of events 1 • 13 months Rectal perforation was considered serious, even if no symptoms develop nor sequela arise.
Renal and urinary disorders Urinary retention	14.3% 1/7 • Number of events 1 • 13 months Rectal perforation was considered serious, even if no symptoms develop nor sequela arise.

Other adverse events

Adverse event data not reported

Additional Information

Galit Itzhaki

BioProtect

Phone: +972-9-7731929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place