NCT00894933 · STUDY IN CONTEXT

Performance Evaluation of the AMS CONTINUUM™ Device

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Subjects in whom device placement was attempted

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primary · POSTED

Defined as the establishment of a water-tight anastomosis immediately post-Device placement.

Subjects in whom device placement was attempted (i.e. treated subjects)

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primary · POSTED

Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)

Source null

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secondary · POSTED

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.

Subjects in whom device placement was attempted

→

secondary · POSTED

Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts

Subjects with successful device placement

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secondary · POSTED

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.

Subjects in whom device placement was attempted

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00894933
trial label: Performance Evaluation of the AMS CONTINUUM™ Device
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0000
source section id
NCT00894933-om-0000
source outcome index
0
endpoint
Safety - Infection That Requires IV Antibiotics or Re-hospitalization
endpoint definition
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
time origin
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Subjects in whom device placement was attempted
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0001
source section id
NCT00894933-om-0001
source outcome index
1
endpoint
Successful Device Placement
endpoint definition
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
time origin
At Device placement
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Subjects in whom device placement was attempted (i.e. treated subjects)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0002
source section id
NCT00894933-om-0002
source outcome index
2
endpoint
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement
endpoint definition
Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)
time origin
7-21 days post-Device placement
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0003
source section id
NCT00894933-om-0003
source outcome index
3
endpoint
Intraoperative/Postoperative Parameters - Estimated Blood Loss
endpoint definition
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
time origin
At Device placement
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Subjects in whom device placement was attempted
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0004
source section id
NCT00894933-om-0004
source outcome index
4
endpoint
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
endpoint definition
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
time origin
7-10 and 13 - 15 days post-Device placement
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Subjects with successful device placement
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0005
source section id
NCT00894933-om-0005
source outcome index
5
endpoint
Intraoperative/Postoperative Parameters - Total Device Placement Time
endpoint definition
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.
time origin
At Device placement
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Subjects in whom device placement was attempted
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0000
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0001
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0002
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0003
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0004
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
outcome key
om-0005
arm key
OG000
arm label
Continuum Device
regimen
Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00894933-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00894933
harm key
EG000
source section id
NCT00894933-ae
event group key
EG000
event group label
Continuum Device
serious affected
3
serious at risk
31
other affected
30
other at risk
31
frequency threshold
0
collection period
Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice