Trial Outcomes & Findings for Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy (NCT NCT02777203)
NCT ID: NCT02777203
Last Updated: 2024-10-24
Results Overview
After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Day 0 through the end of morcellation, approximately 30 minutes.
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Patients Undergoing Myomectomy or Hysterectomy With Morcellation
Subjects undergoing power morcellation with the EcoSac 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Baseline characteristics by cohort
| Measure |
Only One Arm Was Utilized
n=60 Participants
one arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through the end of morcellation, approximately 30 minutes.After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."
Outcome measures
| Measure |
Patients Utilizing EcosacT400 Bag
n=60 Participants
Patients undergoing hysterectomy and myomectomy utilizing morcellation and new EcosacT400 bag
|
|---|---|
|
Number of Participants With Egg Albumin Leakage.
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 through the end of morcellation, approximately 30 minutes.Time (in minutes) from insertion of the bag to removal of the bag
Outcome measures
| Measure |
Patients Utilizing EcosacT400 Bag
n=60 Participants
Patients undergoing hysterectomy and myomectomy utilizing morcellation and new EcosacT400 bag
|
|---|---|
|
Morcellation Time
|
26.3 minutes
Standard Deviation 14.6
|
Adverse Events
Patients Utilizing ecosacT400 Bag
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Utilizing ecosacT400 Bag
n=60 participants at risk
Patients undergoing hysterectomy and myomectomy utilizing morcellation and the EcosacT400 bag
|
|---|---|
|
Renal and urinary disorders
post op urinary retention
|
5.0%
3/60 • Number of events 3 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
umbillical drainage
|
8.3%
5/60 • Number of events 5 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
Incisional pain
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
chest pain
|
3.3%
2/60 • Number of events 2 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Gastrointestinal disorders
diarrhea
|
5.0%
3/60 • Number of events 3 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Infections and infestations
Fever
|
3.3%
2/60 • Number of events 2 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Nervous system disorders
leg numbness
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
Broken instrument
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
bruising around incision sites
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Gastrointestinal disorders
post operative nausea
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
Fatigue
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Skin and subcutaneous tissue disorders
rash
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Injury, poisoning and procedural complications
Peritoneal rent
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Gastrointestinal disorders
constipation
|
1.7%
1/60 • Number of events 1 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
|
Surgical and medical procedures
Vaginal discharge/yeast infection
|
3.3%
2/60 • Number of events 2 • 6 weeks
Patient were followed continuously for six weeks post-operatively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place