Trial Outcomes & Findings for Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation (NCT NCT00997594)
NCT ID: NCT00997594
Last Updated: 2015-04-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
18 participants
Primary outcome timeframe
One day
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
Adrenal Radiofrequency Ablation
Patients who received adrenal radiofrequency (RF) ablation.
|
Abdominal Radiofrequency Ablation Other Than Adrenal Gland
Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
Completion of Ablation Procedure
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Baseline characteristics by cohort
| Measure |
Adrenal Radiofrequency Ablation
n=9 Participants
Patients who received adrenal radiofrequency (RF) ablation.
|
Abdominal Radiofrequency Ablation Other Than Adrenal Gland
n=9 Participants
Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
|
Total
n=18 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
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13 • n=5 Participants
|
71 years
STANDARD_DEVIATION 12 • n=7 Participants
|
65 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One dayOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: around one yearOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 weekBlood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.
Outcome measures
| Measure |
Adrenal Radiofrequency Ablation
n=9 Participants
Patients who received adrenal radiofrequency (RF) ablation.
|
Abdominal Radiofrequency Ablation Other Than Adrenal Gland
n=9 Participants
Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
|
|---|---|---|
|
Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
Outcome data not reported
Adverse Events
Adrenal Radiofrequency Ablation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Abdominal Radiofrequency Ablation Other Than Adrenal Gland
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place