Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

implantation of an absorbable perirectal spacer balloon

Absorbable perirectal spacer implantation

balloon implant

Implantation of the balloon between the prostate and the anterior rectal wall

Balloon implantation

Yossi Muncher, Dr.

Primary Goal

The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.

Secondary Goal

The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Primary Endpoint Parameters

The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:

1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure were defined by the Clinical Trials.gov definition of a serious adverse event. Serious Adverse Events will be documented in Serious Adverse Event Form.
2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events were documented in Adverse Event Form.
3. Subjective discomfort related to the balloon and implantation procedure were assessed by a pain analogue scale.

Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instructions regarding anatomical landmarks delineated in this protocol.

Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.

Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.

BioProtect

The definition used did not differ from the clintrials.gov definition. All data was reviewed for the occurrence of these events. No serious events occurred.

implantation of an absorbable perirectal spacer balloon

balloon implant: Absorbable perirectal spacer implantation

Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall

Balloon Implantation

Age, Categorical

Sex: Female, Male

Shaul Shohat

Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.

Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.

One arm study only

implantation of an absorbable perirectal spacer balloon

balloon implant: Absorbable perirectal spacer implantation

Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall

Overall Study

Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)

biodegradable balloon implant to increase the distance between prostate and anterior rectal wall

Absorbable perirectal spacer

Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events.

Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Primary Endpoint Parameters

The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure:

1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
3. Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.

Secondary Endpoint Parameters

To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:

1. Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment.
2. Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software.

Other Measured Observations

1. Balloon non-displacement during treatment phase as shown by CT.
2. Balloon remaining inflated during treatment phase as shown by CT.
3. Operator satisfaction from BioProtect balloon implantation procedure.

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

One-arm, Multi-center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

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

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.

Rectal perforation was considered serious, even if no symptoms develop nor sequela arise.

Group 1

Implantation of a biodegradable balloon spacer (absorbable perirectal spacer) to increase the distance between prostate and anterior rectal wali.

Balloon Implant

Age, Continuous

Israel

Region of Enrollment

This was an initial human experience feasibility study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects	NCT00918229	Prostate Cancer	balloon implant Balloon implant...	45 Years - 85 Years	BioProtect
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy	NCT00462124	Prostate Cancer	Absorbable peri...	- 80 Years	BioProtect
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy	NCT00462124	Prostate Cancer	Absorbable peri...	- 80 Years	BioProtect
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects	NCT00918229	Prostate Cancer	balloon implant Balloon implant...	45 Years - 85 Years	BioProtect

Spots Global Cancer Trial Database for intrarectal balloon