Trial Outcomes & Findings for Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent (NCT NCT00166361)
NCT ID: NCT00166361
Last Updated: 2014-07-18
Results Overview
Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
baseline to 59 months after placement of stent
Results posted on
2014-07-18
Participant Flow
Patients were recruited from Oncologic practice of the Mayo Clinic, Rochester, Minnesota from February 2004 to May 2011.
29 subjects were enrolled, 4 subjects were screen failures, and were not treated, one subject was treated as a compassionate use patient with a smaller memokath stent.
Participant milestones
| Measure |
Memokath 051 Ureteral Stent
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
|
JJ Stent
Subjects assigned to this arm received a JJ stent.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
10
|
|
Overall Study
COMPLETED
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent
Baseline characteristics by cohort
| Measure |
Memokath 051 Ureteral Stent
n=14 Participants
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
|
JJ Stent
n=10 Participants
Subjects assigned to this arm received a JJ stent.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 59 months after placement of stentStent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.
Outcome measures
| Measure |
Memokath 051 Ureteral Stent
n=14 Participants
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
|
JJ Stent
n=10 Participants
Subjects assigned to this arm received a JJ stent.
|
|---|---|---|
|
Mean Stent Dwell Time
|
17 months
Interval 1.0 to 59.0
|
3.97 months
Interval 2.56 to 5.36
|
Adverse Events
Memokath 051 Ureteral Stent
Serious events: 12 serious events
Other events: 10 other events
Deaths: 0 deaths
JJ Stent
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Memokath 051 Ureteral Stent
n=14 participants at risk
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
|
JJ Stent
n=10 participants at risk
Subjects assigned to this arm received a JJ stent.
|
|---|---|---|
|
Gastrointestinal disorders
Surgery related to underlying disease
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Carcinoid heart disease
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Heart failure related to underlying disease
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Ureteral Obstruction
|
50.0%
7/14 • Number of events 7
|
0.00%
0/10
|
|
Gastrointestinal disorders
Bowel Obstruction
|
28.6%
4/14 • Number of events 4
|
0.00%
0/10
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 2
|
0.00%
0/10
|
|
Renal and urinary disorders
Hospitalization due to disease progression
|
21.4%
3/14 • Number of events 3
|
0.00%
0/10
|
|
Renal and urinary disorders
Edema of ureter
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
Surgical and medical procedures
Stent migrated into bladder
|
7.1%
1/14 • Number of events 2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Dehydration
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Acute renal failure
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Stent encrustation/obstruction
|
28.6%
4/14 • Number of events 6
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Acute Chronic Anemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Hydroureteronephrosis
|
21.4%
3/14 • Number of events 3
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Hospitalization for fractured ankle
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Trouble with stent placement due to faulty guide wire
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Atropy of the kidney
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Nephrectomy
|
0.00%
0/14
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Partial ureterectomy
|
0.00%
0/14
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Hospitalization for sepsis
|
0.00%
0/14
|
20.0%
2/10 • Number of events 2
|
|
Renal and urinary disorders
Hospitalization for urinary tract infection (UTI)
|
0.00%
0/14
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Memokath 051 Ureteral Stent
n=14 participants at risk
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
|
JJ Stent
n=10 participants at risk
Subjects assigned to this arm received a JJ stent.
|
|---|---|---|
|
Cardiac disorders
Essential hypertension
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
2/14 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Flank pain
|
42.9%
6/14 • Number of events 8
|
30.0%
3/10 • Number of events 4
|
|
General disorders
Groin pain
|
21.4%
3/14 • Number of events 3
|
30.0%
3/10 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Iliac pain
|
0.00%
0/14
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
General disorders
Left lower quadrant pain
|
21.4%
3/14 • Number of events 4
|
0.00%
0/10
|
|
General disorders
Right lower quadrant pain
|
0.00%
0/14
|
10.0%
1/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Thigh pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Acid reflux
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Difficulty eating
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
57.1%
8/14 • Number of events 10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
6/14 • Number of events 7
|
0.00%
0/10
|
|
Renal and urinary disorders
Bladder spasms
|
0.00%
0/14
|
10.0%
1/10 • Number of events 2
|
|
Renal and urinary disorders
Decreased renal function
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
|
Renal and urinary disorders
Hydronephrosis
|
50.0%
7/14 • Number of events 8
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal colic
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Ureterectasis
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
Renal and urinary disorders
Urinary tract infections (UTI)
|
64.3%
9/14 • Number of events 19
|
40.0%
4/10 • Number of events 7
|
|
Renal and urinary disorders
Urine leakage
|
0.00%
0/14
|
30.0%
3/10 • Number of events 6
|
|
Renal and urinary disorders
Burning when urinating
|
0.00%
0/14
|
20.0%
2/10 • Number of events 2
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/14
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chills
|
7.1%
1/14 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Deydration
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Fall resulting in fractured ribs
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Flu like symptoms
|
21.4%
3/14 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fever
|
21.4%
3/14 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Fragility
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
General disorders
Headache
|
7.1%
1/14 • Number of events 5
|
0.00%
0/10
|
|
General disorders
Insomnia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Knee weakness
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Night Sweats
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Weight Loss
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Tiredness/fatigue
|
14.3%
2/14 • Number of events 3
|
0.00%
0/10
|
|
General disorders
Weakness
|
14.3%
2/14 • Number of events 2
|
0.00%
0/10
|
|
Nervous system disorders
Vasovagal episode
|
7.1%
1/14 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 2
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place