Trial Outcomes & Findings for Honduras Liger Thermocoagulator Study (NCT NCT03510273)
NCT ID: NCT03510273
Last Updated: 2020-11-27
Results Overview
Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.
COMPLETED
NA
320 participants
1 month after treatment
2020-11-27
Participant Flow
One woman was positive for visual inspection with acetic acid, but after enrollment was found to not have documentation of her human papillomavirus test or test result. Therefore, 320 were enrolled but only 319 participated in the study.
Participant milestones
| Measure |
Thermocoagulation Treatment
Received thermal coagulation treatment for cervical precancer.
|
|---|---|
|
Overall Study
STARTED
|
319
|
|
Overall Study
Treated With Thermal Coagulation
|
319
|
|
Overall Study
Completed 1-mth Follow-up Visit & Exited
|
192
|
|
Overall Study
Completed 1-mth Follow-up Visit & Cont'd
|
126
|
|
Overall Study
Completed All One-year Follow up Visits
|
118
|
|
Overall Study
COMPLETED
|
310
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Thermocoagulation Treatment
Received thermal coagulation treatment for cervical precancer.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Care outside study, ineligible to cont.
|
3
|
|
Overall Study
Moved away from study area
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Thermocoagulation Treatment
n=319 Participants
Received thermal coagulation treatment for cervical precancer.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=319 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
319 Participants
n=319 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=319 Participants
|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 5.2 • n=319 Participants
|
|
Sex: Female, Male
Female
|
319 Participants
n=319 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=319 Participants
|
|
Region of Enrollment
Honduras
|
319 participants
n=319 Participants
|
PRIMARY outcome
Timeframe: 1 month after treatmentPopulation: All participants were included. Note: Participants could report more than one discomfort or problem experienced.
Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.
Outcome measures
| Measure |
Thermocoagulation Treatment
n=319 Participants
Received thermal coagulation treatment for cervical precancer.
|
< CIN2 at Baseline
Biopsy negative at baseline
|
|---|---|---|
|
Short-term Safety Concerns for Ablative Treatment
Severe lower abdominal pain
|
11 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Fever
|
0 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Colorless watery discharge
|
288 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Brown/black discharge
|
106 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Foul-smelling, pus-colored discharge
|
100 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Bleeding
|
31 participants
|
—
|
|
Short-term Safety Concerns for Ablative Treatment
Pain while urinating
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Immediately after treatmentPopulation: Not applicable; all participants were included.
Level of pain women experienced during the thermal coagulation procedure will be calculated by the number and percent of women indicating minimal to worst possible levels of pain using the Wong-Baker FACES® pain rating scale. Women's acceptability will also be assessed by asking if they would recommend the Liger Thermocoagulator treatment to a friend or relative who needed similar treatment as well as reasons for her response. Wong-Baker FACES® pain rating scale: MINIMUM value: 0 (no hurt = best outcome) Value: 2 (hurts little bit) Value: 4 (hurts little more) Value: 6 (hurts even more) Value: 8 (hurts lot more) MAXIMUM value: 10 (hurts whole lot = worst outcome)
Outcome measures
| Measure |
Thermocoagulation Treatment
n=319 Participants
Received thermal coagulation treatment for cervical precancer.
|
< CIN2 at Baseline
Biopsy negative at baseline
|
|---|---|---|
|
Acceptability of Treatment by Women
FACES® level of pain: 0 - no hurt
|
62 Participants
|
—
|
|
Acceptability of Treatment by Women
FACES® level of pain: 4 - hurts little more
|
43 Participants
|
—
|
|
Acceptability of Treatment by Women
FACES® level of pain: 6 - hurts even more
|
30 Participants
|
—
|
|
Acceptability of Treatment by Women
FACES® level of pain: 10 - hurts worst
|
1 Participants
|
—
|
|
Acceptability of Treatment by Women
Would recommend treatment to friend/relative
|
319 Participants
|
—
|
|
Acceptability of Treatment by Women
FACES® level of pain: 8 - hurts whole lot
|
15 Participants
|
—
|
|
Acceptability of Treatment by Women
Would not recommend treatment to friend/relative
|
0 Participants
|
—
|
|
Acceptability of Treatment by Women
FACES® level of pain: 2 - hurts little bit
|
168 Participants
|
—
|
SECONDARY outcome
Timeframe: One time, 12 months after treatmentPercentage of participants with no evidence of cervical intraepithelial neoplasia grade 2 or grade 3 (CIN2-3) at 12 months, based on histological evaluation following the standard criteria from WHO Classification of Tumours, 5th Edition, Volume 4: Female Genital Tumours.
Outcome measures
| Measure |
Thermocoagulation Treatment
n=69 Participants
Received thermal coagulation treatment for cervical precancer.
|
< CIN2 at Baseline
n=49 Participants
Biopsy negative at baseline
|
|---|---|---|
|
Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation
|
91.30 % participants
Interval 81.7 to 96.1
|
97.96 % participants
Interval 86.4 to 99.7
|
SECONDARY outcome
Timeframe: Once, 12 months after treatmentQualitative analysis of cervical photos by an expert colposcopist to explore factors associated with treatment failure, compared characteristics of the cervix and precancerous lesions among women with CIN2-3 at Visit 1 (enrollment) in women whose treatment resulted in lesion disappearance (\<CIN2), and women with persistent lesions (CIN2-3) at 12 months. Adequacy of the image included focus, blur, and capture; a well focused image without obstructions (blood, cysts) that captured the whole ectocervix and cervical os was considered adequate. For squamous columnar junction and transformation zone (TZ) visibility, TZ1 signifies a fully visible TZ, TZ2 signifies the TZ or visible lesions extend into the cervical canal and the TZ covers more than 75% of the ectocervix, and TZ3 signifies that the TZ is not at all visible, in accordance with WHO recommendations. Baseline histology reports histological evaluation of lesions as cervical intraepithelial neoplasia grade 2 (CIN2) or 3 (CIN3).
Outcome measures
| Measure |
Thermocoagulation Treatment
n=5 Participants
Received thermal coagulation treatment for cervical precancer.
|
< CIN2 at Baseline
n=63 Participants
Biopsy negative at baseline
|
|---|---|---|
|
Treatment Failure
Baseline photo: Adequate
|
2 Participants
|
38 Participants
|
|
Treatment Failure
Baseline photo: Inadequate
|
3 Participants
|
25 Participants
|
|
Treatment Failure
Squamous columnar junction visibility: TZ1
|
1 Participants
|
20 Participants
|
|
Treatment Failure
Squamous columnar junction visibility: TZ2
|
1 Participants
|
4 Participants
|
|
Treatment Failure
Visible abnormal areas: 1
|
1 Participants
|
23 Participants
|
|
Treatment Failure
Visible abnormal areas: 2+
|
1 Participants
|
29 Participants
|
|
Treatment Failure
Location of the lesion: Not evaluable
|
1 Participants
|
10 Participants
|
|
Treatment Failure
Mosaic of the worst lesion: No mosaic
|
3 Participants
|
50 Participants
|
|
Treatment Failure
Border of the worst lesion: Sharp
|
4 Participants
|
36 Participants
|
|
Treatment Failure
Possible diagnosis: Not evaluable
|
0 Participants
|
3 Participants
|
|
Treatment Failure
Baseline histology: CIN3
|
2 Participants
|
31 Participants
|
|
Treatment Failure
Size of worst lesion (% coverage): 5-50
|
2 Participants
|
38 Participants
|
|
Treatment Failure
Size of worst lesion (% coverage): >50
|
2 Participants
|
18 Participants
|
|
Treatment Failure
Location of the lesion: Outside the TZ
|
0 Participants
|
10 Participants
|
|
Treatment Failure
Squamous columnar junction visibility: TZ3
|
2 Participants
|
39 Participants
|
|
Treatment Failure
Squamous columnar junction visibility: Missing
|
1 Participants
|
0 Participants
|
|
Treatment Failure
Visible abnormal areas: 0
|
1 Participants
|
8 Participants
|
|
Treatment Failure
Visible abnormal areas: Not evaluable
|
0 Participants
|
2 Participants
|
|
Treatment Failure
Visible abnormal areas: Missing
|
2 Participants
|
1 Participants
|
|
Treatment Failure
Location of the lesion: Inside the TZ
|
4 Participants
|
43 Participants
|
|
Treatment Failure
Mosaic of the worst lesion: Fine
|
0 Participants
|
2 Participants
|
|
Treatment Failure
Mosaic of the worst lesion: Coarse
|
2 Participants
|
7 Participants
|
|
Treatment Failure
Mosaic of the worst lesion: Not evaluable
|
0 Participants
|
4 Participants
|
|
Treatment Failure
Border of the worst lesion: Irregular
|
0 Participants
|
10 Participants
|
|
Treatment Failure
Border of the worst lesion: Not evaluable
|
1 Participants
|
17 Participants
|
|
Treatment Failure
Possible diagnosis: No lesion
|
1 Participants
|
12 Participants
|
|
Treatment Failure
Possible diagnosis: LSIL
|
0 Participants
|
8 Participants
|
|
Treatment Failure
Possible diagnosis: HSIL
|
3 Participants
|
25 Participants
|
|
Treatment Failure
Possible diagnosis: Invasion
|
1 Participants
|
15 Participants
|
|
Treatment Failure
Baseline histology: CIN2
|
3 Participants
|
32 Participants
|
|
Treatment Failure
Size of worst lesion (% coverage): 0-4
|
1 Participants
|
7 Participants
|
Adverse Events
Thermocoagulation Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thermocoagulation Treatment
n=319 participants at risk
Received thermal coagulation treatment for cervical precancer.
|
|---|---|
|
Reproductive system and breast disorders
High pain during procedure
|
5.0%
16/319 • Number of events 16 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Mild bleeding/spotting during procedure (not requiring medical attention)
|
10.0%
32/319 • Number of events 32 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Mild cramping during procedure (not requiring medical attention)
|
7.5%
24/319 • Number of events 24 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
General disorders
Dizziness during procedure (not requiring medical attention)
|
5.0%
16/319 • Number of events 16 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Colorless water discharge within 30 days of procedure (not requiring medical attention)
|
90.3%
288/319 • Number of events 288 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Brown/black discharge within 30 days of procedure (not requiring medical attention)
|
33.2%
106/319 • Number of events 106 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Foul smelling, pus colored discharge within 30 days of procedure (not requiring medical attention)
|
31.3%
100/319 • Number of events 100 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Bleeding within 30 days of procedure (not requiring medical attention)
|
9.7%
31/319 • Number of events 31 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
|
Reproductive system and breast disorders
Attended health facility or saw health provider because of problems.
|
0.00%
0/319 • Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place